Kymanox is hiring for an experienced Device Engineer contractors for our Device Development and Combination Products projects. We are open to candidates in our Raleigh or Boston locations but will also entertain remote candidates. This is a senior position, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients with a deep knowledge in combination products. Experience to include prefilled syringes, auto injectors, nasal devices, inhalers, and/or similar products. The role may serve as key interface for clients as subject matter expert (SME) and technical lead for various programs.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
    • Risk Management
    • Design Inputs
    • Design Verification and Validation (V&V)
    • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

 

Additional responsibilities can include:

  • Functional management and leadership of direct reports within team
  • Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
  • Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
  • Completion of gap assessments against industry regulations or standards
  • Participation in regulatory body inspections or remediation efforts
  • Authoring of response letters to regulatory bodies
  • Development of policies or standard operating procedures
  • Supply chain  and vendor management strategy and compliance
  • Training (internal and external)
  • Technical Project management and meeting facilitation

 

Educational Background:

  • Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
  • Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
  • Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

 

Experience:

  • 5+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors is required.
  • A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. .
  • Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is required 
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications

 

Desired Aptitude and Skill Set:

  • Strong knowledge of ISO13485, ISO14971, CFR 820.30, and EU MDR
  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members and/or direct reports
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

 

The Kymanox Product Development team is seeking individuals with strong technical and/or operations backgrounds in the pharmaceutical/biotechnology industry.

Job Description:

Provide a broad range of project support to Kymanox clients, including technical, quality/compliance, manufacturing, and commercialization challenges. Experience with developing combination products and/or medical devices preferred.Technical Writing, BFMA's DHF or design history files experience needed. Basic responsibilities include:

  • Representing Kymanox to clients as a project core team member.
  • Providing technical leadership and direction to internal and external project teams.
  • Providing mentorship to junior staff, as part of projects or as direct reports.
  • Ensuring compliance to quality and regulatory standards and fostering a positive compliance culture.

Projects may include any of the following technical areas:

  • Providing technical evaluations and recommendations for mitigation(s) of challenges
  • Developing project roadmaps, detailed schedules, and overall project strategy
  • Authoring Design History Files, in real time or retrospectively.
  • Oversight of client testing activities, including combination product/medical device design verification and human factors testing.
  • CMO due diligence, evaluation, and client representation
  • Process improvement and troubleshooting, tech transfer
  • Project management
  • Regulatory evaluation, submission authorship and review
  • Data analysis, including statistical analysis
  • Product design (CAD, 3D printing)

Aptitude and Skill Set:

  • Versatile and adaptable technical skills
  • Able to execute high-profile activities with minimal supervision
  • Extremely detail-orientated and highly organized
  • Managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
  • Strong professional presence and presentation skills
  • Excellent written and oral English communication skills
  • Fast learner with initial confidence tackling new material
  • Seasoned soft skills – high EQ and team player
  • Ability to work effectively with remote team members and/or direct reports
  • Ability to motivate self and others
  • Tackle problems proactively, not waiting for problems to grow unnecessarily
  • Computer and IT savvy
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Expertly solicit and utilize subject matter expert input
  • Value and understand quality
  • Uncompromised honesty and integrity

Educational Background:

Bachelor’s degree in natural science (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

Experience:

5+ years of experience in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.

Region:

Kymanox Corporate HQ in Durham (RTP), NC preferred. Chicago, IL; Boston, MA; King of Prussia, PA, Remote possible.

Travel:

Some travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) may be required.

__________________________________________________________________________________

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and Philadelphia. 

The Kymanox Product Development team is seeking contractors and full-time employees with strong technical and/or operations backgrounds in the pharmaceutical/biotechnology industry.

Job Description:

Provide a broad range of project support to Kymanox clients, including technical, quality/compliance, manufacturing, and commercialization challenges. Experience with developing combination products and/or medical devices preferred.Technical Writing, BFMA's DHF or design history files experience needed. Basic responsibilities include:

  • Representing Kymanox to clients as a project core team member.
  • Providing technical leadership and direction to internal and external project teams.
  • Providing mentorship to junior staff, as part of projects or as direct reports.
  • Ensuring compliance to quality and regulatory standards and fostering a positive compliance culture.

Projects may include any of the following technical areas:

  • Providing technical evaluations and recommendations for mitigation(s) of challenges
  • Developing project roadmaps, detailed schedules, and overall project strategy
  • Authoring Design History Files, in real time or retrospectively.
  • Oversight of client testing activities, including combination product/medical device design verification and human factors testing.
  • CMO due diligence, evaluation, and client representation
  • Process improvement and troubleshooting, tech transfer
  • Project management
  • Regulatory evaluation, submission authorship and review
  • Data analysis, including statistical analysis
  • Product design (CAD, 3D printing)

Aptitude and Skill Set:

  • Versatile and adaptable technical skills
  • Able to execute high-profile activities with minimal supervision
  • Extremely detail-orientated and highly organized
  • Managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
  • Strong professional presence and presentation skills
  • Excellent written and oral English communication skills
  • Fast learner with initial confidence tackling new material
  • Seasoned soft skills – high EQ and team player
  • Ability to work effectively with remote team members and/or direct reports
  • Ability to motivate self and others
  • Tackle problems proactively, not waiting for problems to grow unnecessarily
  • Computer and IT savvy
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Expertly solicit and utilize subject matter expert input
  • Value and understand quality
  • Uncompromised honesty and integrity

Educational Background:

Bachelor’s degree in natural science (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

Experience:

5+ years of experience in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.

Region:

Kymanox Corporate HQ in Durham (RTP), NC preferred. Chicago, IL; Boston, MA; King of Prussia, PA, Remote possible.

Travel:

Some travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) may be required.

__________________________________________________________________________________

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and Philadelphia. 

Kymanox is hiring for an experienced Device Engineer for our Device Development and Combination Products projects. We are open to candidates in our Raleigh or Boston locations but will also entertain remote candidates. This is a senior position, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients with a deep knowledge in combination products. Experience to include prefilled syringes, auto injectors, nasal devices, inhalers, and/or similar products. The role may serve as key interface for clients as subject matter expert (SME) and technical lead for various programs.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
    • Risk Management
    • Design Inputs
    • Design Verification and Validation (V&V)
    • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

 

Additional responsibilities can include:

  • Functional management and leadership of direct reports within team
  • Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
  • Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
  • Completion of gap assessments against industry regulations or standards
  • Participation in regulatory body inspections or remediation efforts
  • Authoring of response letters to regulatory bodies
  • Development of policies or standard operating procedures
  • Supply chain  and vendor management strategy and compliance
  • Training (internal and external)
  • Technical Project management and meeting facilitation

 

Educational Background:

  • Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
  • Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
  • Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

 

Experience:

  • 5+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors is required.
  • A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. .
  • Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is required 
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications

 

Desired Aptitude and Skill Set:

  • Strong knowledge of ISO13485, ISO14971, CFR 820.30, and EU MDR
  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members and/or direct reports
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

 

Kymanox is hiring for a Principal Device Engineer for our Device Development and Combination Products projects. This is a senior position, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients with a deep knowledge in combination products. Experience to include prefilled syringes, auto injectors, nasal devices, inhalers, and/or similar products. The role may serve as key interface for clients as subject matter expert (SME) and technical lead for various programs.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
    • Risk Management
    • Design Inputs
    • Design Verification and Validation (V&V)
    • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

 

Additional responsibilities can include:

  • Functional management and leadership of direct reports within team
  • Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
  • Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
  • Completion of gap assessments against industry regulations or standards
  • Participation in regulatory body inspections or remediation efforts
  • Authoring of response letters to regulatory bodies
  • Development of policies or standard operating procedures
  • Supply chain  and vendor management strategy and compliance
  • Training (internal and external)
  • Technical Project management and meeting facilitation

 

Educational Background:

  • Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
  • Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
  • Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

 

Experience:

  • 7+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors is required.
  • A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. .
  • Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is required 
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications

 

Desired Aptitude and Skill Set:

  • Strong knowledge of ISO13485, ISO14971, CFR 820.30, and EU MDR
  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members and/or direct reports
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

 

Kymanox is growing and looking for an experienced Medical Device Engineer to join our team in our King of Prussia location!

Job Responsibilities:

The Senior Engineer will work alongside a cross functional team to support our customers in the design and development of next generation medical devices and combination products. This engineer will design, develop, prototype, and test cutting edge technologies while interfacing with other engineers from mechanical, electrical, firmware, and quality functions. The Senior Engineer will:

  • Design and prototype device systems and subsystems using CAD and common prototyping techniques such as 3d printing or machining.
  • Perform analytical assessments to inform design directions as needed.
  • Create test plans including test design and determine whether they can be run in-house or need to be outsourced.
  • Support testing function and oversee test method development.
  • Aggregate, analyze, and report on test data and provide feedback to the design team.
  • Identify and mitigate risks associated with device functionality, reliability, safety, COGs and manufacturing scalability.
  • Work with cross-functional teams within the organization.
  • Work within final assembly manufacturing environment(s) and assist in early-stage process development and manufacturing optimization to ensure products meet design intent.
  • Work with and manage external suppliers, conduct DFM reviews, and go onsite as needed.
  • Conduct technology tear-down studies.
  • Design and setup feasibility tests.
  • Develop failure analysis models using simulation tools.
  • Periodically participate in strategic planning activities.
  • Mentor other engineering team members within the organization.

Desired Aptitude and Skillset:

  • Ethical, responsible, and data-driven decision-maker
  • Expertise in the design and manufacture of plastic, rubber, and metal components
  • Strong understanding of material science as it pertains to polymers, metals and glass
  • Flexible and versatile
  • Self-directing, self-pacing, fast learner.
  • Strong verbal/written communication skills
  • Ability to prioritize work in a fast-paced, dynamic environment
  • Excellent problem-solving skills and results oriented.
  • Solid team player
  • Ability to translate product design requirements into specifications that can be tested against methods that can be validated
  • Familiarity with Statistical Process Control (SPC), GD&T; Lean, Six Sigma knowledge, a plus
  • Design for manufacturing (DFM). Automated assembly experience, a plus.
  • PC skills - MS Office Suite, SolidWorks required.

Educational Background:

Bachelor of Science in Science in a related discipline or Engineering from an accredited institution.

Experience:

  • Minimum of 5 years of experience within a product development environment is required, preferably with class II or III medical devices.
  • Experience in product design for high volume manufacture.
  • Strong leadership and project management skills with proven track record within testing and validation.
  • Experience working within New Product Development is required.
  • Knowledge of design controls.
  • Experience in the design of disposable, bio-compatible fluid paths and/or container solutions, a strong plus.
  • A track record of generating novel ideas / IP, a strong plus.
  • Proficiency utilizing MS Office Suite (Word, PowerPoint and Excel etc.), and statistical software tools such as Minitab for data analysis, experiment design, and tolerance interval calculations.
  • Proficiency in solid modeling, preferably with SolidWorks, for the modeling of device components and basic fixtures for test execution; further preference for experience in developing and/or reviewing 2D drawings for fixture components and/or assemblies.
  • Proficiency with Matlab or Python, a strong plus.
  • Experience with the execution and development of methods for Universal Testing Machines including programming custom test routines.
  • Practical experience in the customization of a standard test procedure to a novel product, including test method feasibility development, Gauge R&R evaluation, and pre-validation assessment.
  • Familiarity with the core standards of drug delivery devices, such as ISO 11608 & 11040, as well as practical experience in the test methods described or referenced in those standards, a plus.
  • Familiarity with metrology methods, experience in managing outside vendors for metrology and test execution.

 

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and Philadelphia. 

Kymanox is expanding our Quality team!  This is a contractor role that has potential for FTE. The person in this position will be engaged in supporting Kymanox’s clients with Quality Assurance and Compliance activities, with an emphasis on developing, assessing, and/or improving quality management systems and the underlying quality processes. This role is located in Morrisville, NC but cannot be fully remote. Travel up to 25% is required as needed.  Relevant experience may include any of the following activities:

· Leading audits of client suppliers (component suppliers, manufacturers, laboratories, clinical sites, and distributors) including agenda creation, audit execution, and report writing

· Gap assessments of quality management systems or quality processes against global regulations (e.g. 21 CFR Parts 4, 11, 210/211, 600, 820, ISO 9001, ISO 13485, ISO 14971, EU Annex 1)

· Remediation efforts and CAPA implementation in response to audit findings, compliance gaps, and continuous improvement initiatives

· Participation in quality processes, such as change management, supplier management, deviation/non-conformance management, investigations, annual product review, internal or external auditing, inspection readiness, and inspection facilitation

· Familiarity with various electronic and paper-based quality management systems and how they function throughout the product lifecycle

· Authoring or review of various risk assessments related to product quality and safety

· Author, Format, and Review procedures, methods, manufacturing records, sampling plans, specifications, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice

· Compile and review information to regulatory submissions, inspections or response letters to regulatory bodies

· Technical writing in Microsoft Office suite

Educational Background:

Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent. Advanced degree or industry certifications (e.g., ASQ, ISO) preferred, but not required. 

Experience:

4-10 years of operations or quality assurance experience in pharmaceuticals, biotechnology, and/or medical devices is required.

Desired Aptitude and Skill Set:

· Highly organized and excellent attention to detail

· Ability to follow-up on assignments without reminders

· Good understanding of own limitations

· Fast learner and accepting of change

High energy level

· Pleasant and positive communication style

· Strong customer-service aptitude

· Computer-savvy

· Ability and desire to follow procedures when they exist

· Appreciation for variety

· Technical writing skills (content and format)

· Adept at Microsoft Office suite of products

· Natural ability to exercise confidentiality and discretion with sensitive information

 

Travel:

Up to 25% travel depending on project or client needs.

-------------------------------------

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services from our highly collaborative team of experts, Kymanox provides an outstanding opportunity for learning and career advancement.

 

Kymanox is looking for a motivated individual ready to continue a career in the life sciences at a higher trajectory. Kymanox provides professional services related to science, engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-ups. The company was founded in 2004 and has been growing steadily since its inception.

Kymanox is looking for a Laboratory Supervisor with Medical Device and/or Combination product GMP testing experience to join our team in King of Prussia.

Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston and Chicago. Our testing laboratory is in King of Prussia, Pennsylvania.


Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

 

 

Job Description:

This position is responsible for the oversight of the Neuma medical device and combination product testing laboratory, supporting Kymanox / Neuma clients with Quality Control product testing activities.

 

This is a “working” position where the individual will be expected to contribute at the bench in addition to supervisory activities.

 

This position is based at Neuma (a division of Kymanox) in King of Prussia, Pennsylvania and requires presence on site.

 

Responsibilities include (but are not limited to):

  • Supervision of up to four (4) laboratory technicians
  • Day to day scheduling of QC laboratory activities & testing
  • Oversee laboratory master schedule and long-term planning
  • Sample management for GMP and non-GMP studies
  • Ensure laboratory safety and adherence to requirements
  • Management of laboratory waste streams
  • Ensure training requirements for QC personnel are current and compliant
  • Contribute to laboratory testing and data review as required
  • Ensure instrument calibration & maintenance is current and part of master schedule
  • Onboard and qualify new instrumentation as necessary
  • Author / review / approve GMP documents such as validation protocols, validation reports, test methods, and SOPs.
  • Author / review / approve quality systems events such as deviations and laboratory investigations.
  • Maintain laboratory audit readiness and represent laboratory as part of on-site audits
  • Implement continuous improvement initiatives to improve testing efficiency

 

Educational Background:

  • Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent. Advanced degree or industry certifications (e.g., ISO) preferred, but not required.

Experience:

  • 5+ years of experience in the GMP testing of medical devices, combination products, pharmaceuticals, and/or biotech/biologics is required.
  • 1+ years of personnel management experience preferred
  • Familiarity with GMP requirements, FDA/ICH guidance, ISO standards, and USP is required
  • Experience with pre-filled syringes, co-packaged kits and/or other combination product platforms preferred
  • Specific experience with Design Verification Activities is preferred
  • Familiarity with deviation and non-conformance investigations is preferred

 

Desired Aptitude and Skill Set:

  • Highly organized and excellent attention to detail
  • Ability to follow-up on assignments without reminders
  • Strong analytical skills
  • Fast learner and accepting of change
  • Demonstrates strong accountability
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Thrive in a fast paced, growing, and dynamic work environment
  • Ability to follow procedures when they exist
  • Appreciation for variety
  • Technical writing skills (content and format)
  • Adept at Microsoft Office suite of products
  • Natural ability to exercise confidentiality and discretion with sensitive information

 

Travel: 

Up to 10% travel domestically (primarily) and internationally may be necessary to support client work. 

Division/Region: 

Neuma by Kymanox (King of Prussia, Pennsylvania USA) 

 

Career Development:

The position may evolve over time and responsibilities will be added.  Since Kymanox is a growing company, there will be ample opportunities for advancement – both within the currently defined role, with other groups, and roles to be defined in the future.

Compensation:

Base compensation will be commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.  Eligible for bonus program after 90 days of outstanding work.

 

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, student loan assistance, and other benefits. 

Kymanox is looking for a Senior Quality Engineer with Medical Device and/or Combination product experience to join our team!

Job Description:

This position will be engaged in leading key aspects of Kymanox’s Medical Device and Combination product client base, which includes Product Development, Risk Management and Life Cycle Management. This position will support clients with device design, product testing, hazard identification and cover a wide range of engineering, compliance, and commercialization challenges related to complex combination products (e.g., biologic-device, drug-device). Work closely with medical KOL's and clients at their offices.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
    • Risk Management
    • Design Inputs
    • Design Verification and Validation (V&V)
    • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

Additional responsibilities can include:

  • Functional management and leadership of direct reports within team
  • Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
  • Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
  • Completion of gap assessments against industry regulations or standards
  • Participation in regulatory body inspections or remediation efforts
  • Authoring of response letters to regulatory bodies
  • Development of policies or standard operating procedures
  • Supply chain  and vendor management strategy and compliance
  • Training (internal and external)
  • Technical Project management and meeting facilitation

Educational Background:

  • Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
  • Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
  • Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

Experience:

  • 6-8+ years of experience in development and/or manufacturing, in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
  • This is a senior-level position at Kymanox. A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. 
  • Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is desired.
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications

Desired Aptitude and Skill Set:

  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members and/or direct reports
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

About Kymanox:
Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and New Jersey.

The Kymanox Product Development team is a Senior level Product Development Engineer with a strong technical and/or operations background in the pharmaceutical/biotechnology industry.

Job Description:

Provide a broad range of project support to Kymanox clients, including technical, quality/compliance, manufacturing, and commercialization challenges. Experience with developing combination products and/or medical devices preferred.Technical Writing, BFMA's DHF or design history files experience needed. Basic responsibilities include:

  • Representing Kymanox to clients as a project core team member.
  • Providing technical leadership and direction to internal and external project teams.
  • Providing mentorship to junior staff, as part of projects or as direct reports.
  • Ensuring compliance to quality and regulatory standards and fostering a positive compliance culture.

Projects may include any of the following technical areas:

  • Providing technical evaluations and recommendations for mitigation(s) of challenges
  • Developing project roadmaps, detailed schedules, and overall project strategy
  • Authoring Design History Files, in real time or retrospectively.
  • Oversight of client testing activities, including combination product/medical device design verification and human factors testing.
  • CMO due diligence, evaluation, and client representation
  • Process improvement and troubleshooting, tech transfer
  • Project management
  • Regulatory evaluation, submission authorship and review
  • Data analysis, including statistical analysis
  • Product design (CAD, 3D printing)

Aptitude and Skill Set:

  • Versatile and adaptable technical skills
  • Able to execute high-profile activities with minimal supervision
  • Extremely detail-orientated and highly organized
  • Managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
  • Strong professional presence and presentation skills
  • Excellent written and oral English communication skills
  • Fast learner with initial confidence tackling new material
  • Seasoned soft skills – high EQ and team player
  • Ability to work effectively with remote team members and/or direct reports
  • Ability to motivate self and others
  • Tackle problems proactively, not waiting for problems to grow unnecessarily
  • Computer and IT savvy
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Expertly solicit and utilize subject matter expert input
  • Value and understand quality
  • Uncompromised honesty and integrity

Educational Background:

Bachelor’s degree in natural science (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

Experience:

7+ years of experience in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.

Region:

Kymanox Corporate HQ in Durham (RTP), NC preferred. Chicago, IL; Boston, MA; King of Prussia, PA, Remote possible.

Travel:

Some travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) may be required.

__________________________________________________________________________________

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and Philadelphia. 

The Quality and Compliance team at Kymanox is growing and hiring a contract Senior or Principal Compliance Specialist to join the team. This position has the potential to convert to a full time position.

The person in this position will be engaged in supporting Kymanox’s clients with Quality Assurance and Compliance activities, with an emphasis on developing, assessing, and/or improving quality management systems and the underlying quality processes.  

Relevant experience may include any of the following activities:

  • ·Leading audits of client suppliers (component suppliers, manufacturers, laboratories, clinical sites, and distributors) including agenda creation, audit execution, and report writing
  •   Gap assessments of quality management systems or quality processes against global regulations (e.g. 21 CFR Parts 4, 11, 210/211, 600, 820, ISO 9001, ISO 13485, ISO 14971, EU Annex 1)
  • · Remediation efforts and CAPA implementation in response to audit findings, compliance gaps, and continuous improvement initiatives
  • · Participation in quality processes, such as change management, supplier management, deviation/non-conformance management, investigations, annual product review, internal or external auditing, inspection readiness, and inspection facilitation
  • · Familiarity with various electronic and paper-based quality management systems and how they function throughout the product lifecycle
  • · Authoring or review of various risk assessments related to product quality and safety
  • · Author, Format, and Review procedures, methods, manufacturing records, sampling plans, specifications, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice
  • Compile and review information to regulatory submissions, inspections or response letters to regulatory bodies
  • Technical writing in Microsoft Office suite

Educational Background:

Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent. Advanced degree or industry certifications (e.g., ASQ, ISO) preferred, but not required. 

Experience:

4-10 years of operations or quality assurance experience in pharmaceuticals, biotechnology, and/or medical devices is required.

 

Desired Aptitude and Skill Set:

  • · Highly organized and excellent attention to detail
  • · Ability to follow-up on assignments without reminders
  • ·Good understanding of own limitations
  • Fast learner and accepting of change
  • High energy level
  •  Pleasant and positive communication style
  • Strong customer-service aptitude
  • Computer-savvy
  • Ability and desire to follow procedures when they exist.
  • Appreciation for variety
  • Technical writing skills (content and format)
  • Adept at Microsoft Office suite of products
  • Natural ability to exercise confidentiality and discretion with sensitive information

 

Travel:

Up to 25% travel depending on project or client needs.

_______________________________________________

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services from our highly collaborative team of experts, Kymanox provides an outstanding opportunity for learning and career advancement.

 

Kymanox is looking for a motivated individual ready to continue a career in the life sciences at a higher trajectory. Kymanox provides professional services related to science, engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-ups. The company was founded in 2004 and has been growing steadily since its inception.

Kymanox is hiring a Contract Quality Engineer to support our team at the Petersburg, VA site.

Job Description

The Contract Quality Engineer will support the Quality Engineering team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.  The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.  Responsibilities of the position include establishing and maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications. 

The role supports the Manager of Quality Engineering through oversight and compliance support to Civica’s biologic similar Insulin pre-filled injectable pen program to ensure FDA requirements are met. 

Essential Duties and Responsibilities:

  • Quality and compliance oversight of System and Product workstreams directly supporting biological products in Civica’s pipeline. This includes:
    • Combination product development activity oversight
      • Pharmaceutical process validation in accordance with current regulations (e.g., 21 CFR 210, 211 and FDA Process Validation Guidance-2012)
      • Device development and design controls in accordance with current regulations (e.g., 21 CFR 820 and ISO 13485)
    • Provides Quality oversight of documentation and physical activities supporting systems and processes.
    • Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
    • Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, and investigations.
    • Participate or lead in quality risk analysis.
    • Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
    • Promote a quality mindset and quality excellence approach to all activities.
    • Promote a safety mindset and focus on safety for all operations activities.

 

 

Basic Qualifications and Capabilities:

  • A combination of education and experience, at a minimum holding a bachelor’s degree in a scientific discipline and a minimum of 5 years of experience directly related to the Essential Duties and Responsibilities.
  • Direct Device Master Record (DMR) management experience.
  • Direct technical drawing review and approval experience.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications:

  • Experience in facility, utilities and equipment qualification, computer and process validation, calibration and maintenance and data integrity.
  • Experience and/or certification in statistical techniques.
  • Experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
  • Technical expertise in combination product and medical devices.

Physical Demands and Work Environment:

This role will be expected to be on site for 80% of the work week, with exception of one day remote per week. In addition, the role will be required to be on site to perform Essential Duties and Responsibilities when physical activities are being performed on site.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. 

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

________________________

About Kymanox: 

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey. 

Kymanox is hiring for a Principal Device Engineer for our Device Development and Combination Products projects. We are open to candidates in our Raleigh or Boston locations but will also entertain remote candidates. This is a senior position, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients with a deep knowledge in combination products. Experience to include prefilled syringes, auto injectors, nasal devices, inhalers, and/or similar products. The role may serve as key interface for clients as subject matter expert (SME) and technical lead for various programs.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
    • Risk Management
    • Design Inputs
    • Design Verification and Validation (V&V)
    • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

 

Additional responsibilities can include:

  • Functional management and leadership of direct reports within team
  • Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
  • Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
  • Completion of gap assessments against industry regulations or standards
  • Participation in regulatory body inspections or remediation efforts
  • Authoring of response letters to regulatory bodies
  • Development of policies or standard operating procedures
  • Supply chain  and vendor management strategy and compliance
  • Training (internal and external)
  • Technical Project management and meeting facilitation

 

Educational Background:

  • Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
  • Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
  • Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

 

Experience:

  • 7+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors is required.
  • A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. .
  • Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is required 
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications

 

Desired Aptitude and Skill Set:

  • Strong knowledge of ISO13485, ISO14971, CFR 820.30, and EU MDR
  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members and/or direct reports
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

 

Kymanox is looking for an experienced Senior Technical Project Manager with experience in the Life Sciences - Biologics industry to join our team. The position requires experience in Project/ Program Management, Medical Device Development and Design Controls, and post commercialization of medical devices and combination products. This position is client facing and will be responsible for managing in matrixed organization across multiple departments. Candidates must be located wihtin a commutable distance from the Boston, MA area. 

  • Provide a wide-range of support on a portfolio of two to five projects covering a wide range of engineering, compliance, and commercialization challenges.  Provide project leadership utilizing industry standard Project management tools and integrating the support of multiple engineers and experienced SMEs. Projects may include any of the following focus areas:
    • Medical Device Development and Design Controls
    • Combination Product Commercialization (e.g., Biologic-Device)
    • Process and Product Development
    • Design Verification and Validation
    • Process Validation and Validation Planning 
    • Process Improvement and Troubleshooting
    • Technical Report Authorship, Review, and Formatting
    • Manufacturing Investigations and CAPA/Deviation Closure
    • Biologic Manufacturing Scale-Up and Technology Transfer
    • FDA 483 and Warning Letter Remediation
    • Process and Facility Design to Support Next Gen Drug Manufacturing
    • Data Analysis, Including Statistical Analysis
    • Quality Management System Support
  • Perform additional responsibilities as requested or assigned.

Desired Aptitude and Skill Set:

    • Project Management in accordance with PMI.org and Kymanox
    • Works cooperatively in a matrixed team environment
    • Able to lead high-profile projects with minimal supervision
    • Extremely detail-orientated and highly organized
    • Managerial (i.e., “do things right”) and Leadership (i.e., “do the right thing”) skills
    • Strong professional presence and presentation skills
    • Excellent written and oral English communication skills
    • Fast learner with initial confidence tackling new material
    • Seasoned soft skills – high EQ and team player
    • Ability to motivate self and others
    • Tackle problems proactively, not waiting for problems to grow unnecessarily
    • Computer and IT savvy
    • Thrive in a fast-paced, growing, and dynamic work environment
    • Expertly solicit and utilize subject matter expert input
    • Value and understand quality
    • Uncompromised honesty and integrity

Educational Background:

Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs preferred but not required.

Experience:

  • 10+ years of proven experience in the biopharma and/or medical device industries (i.e., Life Science) with knowledge in two or more of the following practice areas:
    • Project Management or Program Management
    • CGMP Manufacturing (Pharma, Biotech, Device)
    • Quality Engineering
    • Validation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer)
    • Process Engineering, Technical Services, Manufacturing Sciences
    • Quality Control or Analytical Science
    • Technology Transfer
    • Clinical or Medical Services
    • Late State Process or Product Development (Pharma, Biotech, Device)

Travel: 

Local travel within the assigned region and surrounding areas is required.  
____________________________________________

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and New Jersey.

Kymanox is seeking a Human Factors (HF) Consultant/Engineer to join the Human Factors Regulatory and Strategy Business Unit. The HF Engineer will work alongside experts in Human Factors and Usability Engineering and support Kymanox projects which provide professional services for its Biomedical, Pharmaceutical and Medical Device Clients.

Educational Background:

Bachelor’s degree in a science related field such as Biomedical Engineering, Cognitive Engineering or Human Factors. Master’s preferred, but not required.

Experience:

  • A minimum of 5-7 years’ experience working as a Human Factors Engineer at the FDA or in the Medical Device or Pharmaceutical industries

  • Drafting responses to FDA correspondence and communications

  • Drug/Device Combination product/Medical Device and HE Execution experience

  • Drafting HF documentation in support of submission to FDA/notified bodies.
  • Familiarity with FDA Guidance and ISO standards on Human Factors including, but not limited to:

         - FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices, February 2016
         - ANSI/AAMI/IEC 62366 1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. Usability engineering process.
         - ISO 14971:2007. Medical devices — Application of risk management to medical devices

  • Knowledge and experience with 21 CFR 820.30 Design Controls as well as CFR part 4 requirements for Drug/Device combination products
  • Experience in Usability Risk Management including using use risk analyses tools such as hazard analyses, Use FMEA, Task Analyses, and other risk assessments
  • Strong Technical Writing experience and HF/UFE Report writing in accordance with FDA HF Guidance
  • Experience writing protocols and reports for Preliminary Evaluations (Formative Studies) as well as User Interface Design Validation Studies, and experience with conducting and/or moderating HF Studies
  • HF Project Management experience preferred

The Human Factors Engineer will support clients in the above aforementioned HF practices and aid in execution of client HF programs. The Human Factors Engineer will have the opportunity to develop his or her skillset with HF strategy working with seasoned leadership in HF, both from industry and from the FDA.

Desired Aptitude and Skill Set:

  • Extremely detail oriented
  • Ability to work effectively with remote team members
  • Highly organized
  • Resourceful
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Ability to motivate self and team members
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy 

Travel: 

Up to 5-10% remote travel may be required from time to time. 

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey. 

Kymanox is adding an experienced Business Development Manager to our team to help grow our Northeast portfolio! Ideal candidates will have past experience as an Engineer or similar role within the Medical Device, Cell and Gene Therapy, Pharma, or Biotech space

The Business Development Manager will work directly with the Chief Revenue Officer to build new client relationships, secure new projects (revenue), help our clients meet their objectives, and achieve the Company’s sales goals.. At Kymanox we utilize a collaborative sales approach so that account managers, technical leaders and business development work together to identify and address our customers needs and grow the business.

 (New England are required, Boston area preferred)

Responsibilities:

  • Work directly with Account Managers on assigned accounts to expand utilization of services and strategize on prospecting in additional therapeutic areas.
  • Responsible for identifying, qualifying, and closing business in the Life Science industry.
  • Build, maintain and manage a sales pipeline and forecast to achieve company revenue goals.
  • Follow up on warm leads to convert into new business.
  • Write proposals/solutions for project opportunities.
  • Help resolve client challenges, conflicts, and concerns.
  • Build a trusted/strategic relationship with decision-makers on the client-side.
  • Monitor and maintain client relationships to identify partnership/contract growth opportunities.
  • Create and deliver quarterly client presentations, including quarterly business reviews and action plans.
  • Work closely with the Operations teams to accurately forecast and recognize potential client revenue.
  • Collaborate internally to help strengthen organizational processes to create and improve delivery efficiencies.
  • Attend events and conduct lead generation campaigns to discover new project opportunities.
  • Actively promote the company’s profile and brand by participating in tradeshows, association events, and conferences. Identify and attend key conferences and trade shows to increase company visibility business opportunities.
  • Keep CRM updated with all lead and opportunity information.
  • Partner with team to help evaluate partnerships, potential mergers, and acquisitions.

Experience:

  • Bachelor’s degree preferably with a STEM degree (Science, Math, or Engineering) from an accredited institution.
  • The ideal candidate will have 5+ years of experience in Sales or Business Development.
  • Sales experience in the Life Sciences industry is required.
  • Experience in Pharmaceutical, Biomedical and/or Medical Device is preferred. We do a lot of work in the combination product and pharmaceutical product life cycle space.
  • Experience with managing or selling professional services and subject matter expertise in preferred.
  • Proven track record in developing new relationships & cross-selling current accounts.
  • Previous experience with a CRM (Salesforce) preferred.
  • Experience with MS Office products (Outlook, Excel, PowerPoint) preferred.

Desired Aptitude and Skill Set:

  • Detail-oriented
  • Strong communication and customer presentation skills
  • Critical thinking and analytical skills as well as good written, verbal, interpersonal, and negotiating skills
  • Highly motivated self-starter with a sense of ownership and willingness to learn
  • Independent achiever focused on meeting and exceeding sales goals
  • Proven ability to provide consultative sales
  • Excellent problem-solving skills
  • Strong project management skills and a bias for action
  • Ability to form partnerships with clients and internal stakeholders
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Strong customer-service aptitude
  • Seasoned soft skills (i.e., high EQ)
  • Technology savvy

 

Travel:

Up to 30% remote travel domestically and internationally is possible. A passport is required for this job.

 

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About Kymanox: 

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.  

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey. 

 

Kymanox is looking for a Quality Control Specialist to join our team in Morrisville, NC. Reporting to our Manager of Quality Control, this person will be engaged in supporting Kymanox’s clients with Quality Control related activities.

Responsibilities may include:

  • Directly support and provide subject matter expertise related to all disciplines of Quality Control including, but not limited to, Chemistry, Biochemistry, and Microbiology/Environmental Monitoring related projects
  • Author, Format, and Review procedures, methods, manufacturing records, sampling plans, specifications, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice 
  • Author, Format, and Review Technical Protocols and Reports covering, but not limited to analytical method validation and transfer
  • Oversee or support quality management system elements, such as deviations, nonconforming products, corrective and preventive actions, change management, supplier management, etc.
  • Implement or support phase appropriate incoming raw material qualification and testing
  • Project management and meeting facilitation
  • Support auditing and gap assessments against industry regulations or standards for component suppliers, manufacturers, and laboratories, through audit scribing and auditing
  • Perform additional responsibilities as requested or assigned

Desired Aptitude and Skill Set:

  • Highly organized and excellent attention to detail
  • Ability to follow-up on assignments without reminders
  • Good understanding of own limitations
  • Fast learner and accepting of change
  • Able to effectively prioritize work assignments.
  • Commitment to lifelong learning
  • High energy level
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Computer-savvy
  • Ability and desire to follow procedures when they exist
  • Appreciation for variety
  • Technical writing skills (content and format)
  • Adept at Microsoft Office suite of products
  • Natural ability to exercise confidentiality and discretion with sensitive information

Experience:

  • 5+ years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sectors is essential.
  • Specific experience with technical document drafting/review/approvals (e.g.,SOPs, methods, protocols, and reports)
  • Familiarity with risk management tools and applications for life sciences
  • QMS experience required
  • Proficient in MSWord and Excel 

About Kymanox: 

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services from our highly collaborative team of experts, Kymanox provides an outstanding opportunity for learning and career advancement. 

 

Kymanox is looking for a motivated individual ready to continue a career in the life sciences at a higher trajectory. Kymanox provides professional services related to science, engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-ups. The company was founded in 2004 and has been growing steadily since its inception. 

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Additional Information:

Travel: 

Up to 30% travel domestically (primarily) and internationally is necessary to support client work. 

 

Career Development:

The position may evolve over time and responsibilities will be added.  Since Kymanox is a growing company, there will be ample opportunities for advancement – both within the currently defined role, with other groups, and roles to be defined in the future.

 

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, student loan assistance, and other benefits. 

 

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.


 

Kymanox is seeking a Quality Specialist (QMS) to join the QA and Compliance department. The Specialist will work alongside experts in Manufacturing Quality, Compliance, Quality Systems, and Quality Technical Servies to support Kymanox projects which provide professional services for its Biomedical, Pharmaceutical and Medical Device Clients.

The Specialist will support clients in the various service offerings across quality, regulatory, and compliance. The Specialist will have the opportunity to develop his or her skillset within quality systems, manufacturing quality, investigational services, and compliance and auditing.

Job Description:

  • Directly support and provide subject matter expertise related to all disciplines of Quality including, but not limited to, Quality Control, Quality Assurance/Compliance, Quality Management Systems related projects
  • Directly and/or indirectly perform project management roles for projects assigned within primary focus areas of Quality.
  • Author, Format, and Review procedures, methods, manufacturing records, sampling plans, specifications, technical protocols and reports, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice 
  • Experience with analytical method validation, method transfer, process validation, and equipment qualification
  • Provide quality oversight and subject matter expertise of Quality related change controls, deviation product impact assessments, Out of Specification (OOS), Out of Trend (OOT), CAPAs, non-conformances, supplier management, product complaints, and adverse events
  • Assist in the interpretation and implementation of compendial changes to maintain current practice with USP, EP, and JP pharmacopeias
  • Compile and review information to regulatory submissions, inspections or response letters to regulatory bodies
  • Deliver training related to Current Good Manufacturing Practices, Data Integrity, Good Documentation Practices, Good Clinical Practices, Good Distribution Practices, or similar topics
  • Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables.
  • Support auditing and gap assessments against industry regulations or standards for component suppliers, manufacturers, laboratories, clinical sites, and distributors through audit scribing, auditing, report authoring, and correspondence with suppliers/auditees

Desired Aptitude and Skill Set:

  • Flexible and versatile
  • Highly organized
  • Resourceful
  • Self-directing, self-pacing, fast learner
  • Excellent written and oral English communication and presentation skills
  • High energy level
  • Appreciation for variety
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Thrive in a fast-paced, growing, and dynamic work environment

Required Educational Background:

Bachelor of Science in Science-related discipline or Engineering (Chemical, Biomedical, or a related discipline, etc.) from an accredited institution. Advanced degree or industry certifications (e.g., ASQ, ISO) preferred, but not required. 

Required Experience:

  • 5-10 years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sectors is essential.
  • Possesses a diverse background relating to pharmaceutical, biologics or gene/cell therapy development, and/or drug/device combo development, including direct working knowledge of Quality Control, Quality Assurance and/or Quality Enterprise systems.
  • Direct experience with, and application of, project management concepts and tools.
  • Direct knowledge of statistical analysis and related tools and programs.
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation.
  • Possesses a strong business acumen and ability to engage, build, and maintain strong client relationships.
  • Possesses experience with Electronic Document Management Systems (EDMS) and electronic Quality Management Systems (eQMS). 

Estimated Travel:

Local travel within the assigned region and surrounding areas is required. Up to 30% remote travel may be required from time-to-time.
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About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.


Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.