Is Kymanox the right fit for you? 

  

You want to make a difference and have an impact… 

You enjoy having an influence in your day to day work… 

You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow… 

You wake up every day and do what you do 

… because patients deserve better. 

  

 

If this sounds like you, you’ve come to the right place. 

  

 

Job Description: 

The Primary Packaging Engineer will work with cross functional teams to develop, test, validate, and commercialize pharmaceutical & device package solutions for both new and existing products. He/she will support continuous improvements as well as problem resolution and redesign when required for marketed products. The candidate will work in compliance with relevant industry standards as well as customer guidelines (standards) and be responsible for: 

·         Developing, reviewing, and approving the following packaging documents: packaging component specifications, packaging Bills of Materials, packaging component drawings, design history files (for combination products), risk/criticality assessments, and procedures for bulk and finished drug product.   

·         Designing packaging systems for small and large molecule drug products including materials for primary, secondary, and tertiary packaging as well as equipment automation for those processes. 

·         Leading or supporting primary packaging related regulatory filings. 

·         Ownership of distribution testing, shipping studies, line trials, packaging material qualifications, child resistant requirements, human factor studies and patient centric designs. 

·         Identification and validation of secondary and tertiary package materials and suppliers.  

·         Leading and/or participating in harmonization/standardization, quality risk remediation/reduction, and continuous improvement projects that may span across several customers.  

·         Partnering with customers’ marketing groups to effectively support packaging and graphic requirements.  

·         Partnering with customers’ Regulatory Affairs & Global Graphics Services to effectively incorporate copy and legal content to package components.  

·         Developing, tracking, and maintaining project plans and budgets for packaging related projects.  

·         Originating and developing new packaging projects and initiatives that lead to process improvements & have a significant business impact.  

·         Supporting sustainability / green packaging initiatives as required. 

  

Desired Aptitude and Skill Set: 

  • ·    Flexible and versatile
  • ·    Highly organized
  • ·    Resourceful
  • ·    Strong project management skills
  • ·    Self-directing, self-pacing, fast learner
  • ·    Ability to lead and/or support multiple project teams simultaneously

·         Excellent written and oral English communication 

  • Appreciation for variety
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • 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

  

Educational Background: 

Bachelor of Science in Science-related discipline or Engineering from an accredited institution. Degree within Packaging is preferred. 

  

Experience: 

·         Bachelor’s degree with 5 - 10 years of professional experience in pharmaceutical (sterile product manufacturing is preferred) or medical device industries. 

       Experience developing primary container designs and specifications and supporting primary packaging related regulatory filings. 

  • Strong leadership and project management skills with proven track record within Packaging and/or Engineering.
  • Experience working within New Drug Product Development is preferred.
  • Experience in Serialization and Track and Trace for pharmaceutical products.
  • Experience with graphics and labeling of packaging components.
  • Solid background in primary packaging components such as glass and plastic containers, rubber closures, seals, syringes.
  • Experience in writing, executing, reporting, and presenting packaging system evaluations.
  • Strong understanding of global regulations regarding packaging.
  • Knowledge of line trial, equipment qualification, and validation practices are required.
  • Knowledge of combination products, design controls, and ISTA standards and application to pharma & medical device products.
  • Proficiency utilizing MS Office Suite (Word, PowerPoint, Excel, etc.), AutoCAD, and TOPs/CAPE Pallet Patter programs are preferred.

 

 

About Kymanox:  

Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive. 

  

By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better. 

  

Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel. 

  

  

 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. 

Is Kymanox the right fit for you?     
You want to make a difference and have an impact…    
You enjoy having an influence in your day to day work…    
You are motivated by working alongside a team filled with subject matter experts   that  will help you learn and grow…    
   
You wake up every day and do what you do    
   
… because patients deserve better.    
   
If this sounds like you, you’ve come to the right place.   
   
The Kymanox Product Development team is seeking experienced Product Development Engineer/Scientist with strong technical and/or operations backgrounds in the pharmaceutical/biotechnology or medical device industries.   
   
   
Job Description:   
   
Utilizes expertise in technical leadership and program management to advance client product development projects in the medical device and combination product space.     
   
Basic responsibilities include:   
  • Representing Kymanox to clients as a subject matter expert and thought leader.
  • Providing technical leadership and direction to internal and external project teams.
  • Providing mentorship to junior staff.
  • Ensuring compliance to internal and client 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.
  • 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
  • Program management of technically complex, multi-year development programs
  • Regulatory evaluation, submission authorship and review
  • Expert-level statistical analysis of development and production data

   

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
  • A mindset of innovation and creativity
  • Comfortable providing feedback and influencing internal and external stakeholders
  • 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:   
   
Advanced degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.   
   
   
Experience:   
Position will be filled at the Senior or Principal level, commensurate with experience.    
   
  • Minimum 7 years (Senior) or 15 years (Principal) experience (including advanced degrees) in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.
   
  • Additional desirable experience includes leadership of complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or electromechanical systems development. Candidates with experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.

   

   
Region:   
Kymanox Corporate HQ in Morrisville, NC or King of Prussia, PA preferred. Remote possible.   
   
   
Travel:   
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) are required.   
   
   
___________   
   
   
About Kymanox    
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer , advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride … because patients deserve better.    
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.    
   
   
   
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.    
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Quality Assurance Specialist (Contract) on-site with our client in San Jose, California.
      
Primary Responsibilities:
  • Perform investigations per established procedures
  • Support problem solving and troubleshooting as part of investigations
  • Generate quality records as needed (CAPAs, CCs) to support process improvements
  • Review laboratory records (test packets, logbooks, etc.) and ensure they have acceptable Good Documentation Practices and are following procedures
  • Update and draft standard operating procedures and work instructions
  • Communicate effectively with all team members
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline
  • 4 years of experience in a quality assurance setting
  • Direct experience in record review, investigations, and root cause analysis
  • Good understanding and compliance with principles of Good Documentation Practices
  • Strong organizational and time management skills
  • Excellent attention to detail
  • Strong analytical skills
  • Succeed when working independently and as part of a team
  • Demonstrated work ethic and accountability
Preferred Qualifications:
  • Experience working within a quality system (e.g. Veeva)
  • Thrive in a fast paced, growing, and dynamic work environment
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
 

Is Kymanox the right fit for you?  
       
       
You want to make a difference and have an impact…         
You enjoy having an influence in your day to day work…         
You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow…         
You wake up every day and do what you do         
       
… because patients deserve better.         
       
If this sounds like you, you’ve come to the right place.         
       
       
Job Description:       
       
Kymanox is hiring for an Engineer, Device Development and Commercialization for our Device Development and Combination Products projects. This is a mid-level role, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams. This role will be based in Boston, MA.       
       
       
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:       
  • 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
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
Required 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
____________________       
         
About Kymanox:          
       
         
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.         
          
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.         
          
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.       
           
__________________

Travel:          
Up to 10% travel domestically (primarily) and internationally may be 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 payment 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.        
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Process Engineer (Contract) on-site with our client in Princeton, New Jersey.
      
 
Primary Responsibilities:
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Support start-up of biotechnology, cell & gene therapy, and pharmaceutical manufacturing facilities
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Computerized Maintenance Management System (CMMS) implementation and qualification
  • Directly and/or indirectly perform project management roles for projects assigned within primary focus areas
  • Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables
 
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline
  • 3-7 years of experience in the biotech/biologics, cell/gene therapy, and/or pharmaceutical/drug sectors
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Process development, scale-up, qualification, and/or technology transfer
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Direct or indirect experience with project management concepts and tools
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Senior Process Engineer (Contract) on-site with our client in Princeton, New Jersey.
      
 
Primary Responsibilities:
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Support start-up of biotechnology, cell & gene therapy, and pharmaceutical manufacturing facilities
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Computerized Maintenance Management System (CMMS) implementation and qualification
  • Directly and/or indirectly perform project management roles for projects assigned within primary focus areas
  • Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables
 
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline
  • 7-15 years of experience in the biotech/biologics, cell/gene therapy, and/or pharmaceutical/drug sectors
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Process development, scale-up, qualification, and/or technology transfer
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Direct or indirect experience with project management concepts and tools
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Senior Technical Project Manager who will join our Project Management Office and play a key role in leading and providing project management services to clients in the life sciences on a portfolio of two to five projects, or one to two programs, covering a wide range of engineering, compliance, and commercialization challenges. Support will include project leadership utilizing the Kymanox PM Toolkit and integrating the support of multiple engineers and experienced SMEs. This is a hybrid role involving remote work, a regular presence on-site at our office in King of Prussia, PA, as well as ad-hoc travel to client sites in the surrounding areas. 
      
 
Primary Responsibilities:
  • Provide technical project management for pharmaceutical or biotechnology clients.
  • Serve as the primary point of contact on one or multiple client projects and may also serve as the technical lead, if required.
  • Participate in and supports a matrixed team environment with organization and detail-oriented initiatives.
  • Develop policies or standard operating procedures to support internal or client projects.
  • Contribute towards developing project management best practices and facilitating adoption of best practices throughout the company.
  • Complete assigned training requirements (internal and external).
  • Work independently and with minimal oversight and support while, at the same time, provide client stakeholders detailed status and communication updates to facilitate such independence.
  • As assigned, support both early and late-stage programs, including development work and CGMP manufacturing (e.g., technology transfers, scale-ups).
  • For all assigned projects, provide detailed and documented oversight on scope, schedule, budget, and risks and drive program milestones to successful completion.
  • Provide technical lead advisement as applicable and facilitate decision-making processes for key decisions impacting client programs.
  • Run client meetings with pre-published agendas and prepare meeting minutes, including risk tracking, escalations, action items, and decisions.
  • Manage project schedules and ensure resources are assigned and aware of key milestones that need to be met.
  • Rapidly establish relationships with key client personnel by being on-site as much as possible. Manage on-site time to levels required by the project and as directed by client.
  • Maintain flexible work schedule to ensure activities are completed on time, which could necessitate working outside of normal business hours at times.
 
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline is required. Advanced degree (e.g. master's degree, PhD) preferred.
  • Relevant industry certification (e.g., PMP) is desired.
  • 7 years of work experience, including experience in project or program management.
  • Minimum of 5 years experience in a direct, specialized project management role.
  • Experience in one or more of the following areas:
    • Combination product development and design controls
    • Device design, engineering, and testing
    •  Facility and utilities engineering, commissioning, qualification, and validation
  • Ideal candidates will demonstrate a mix of past proven experience in both large and small operating companies, in roles spanning multiple disciplines with evolving levels of responsibility.
 
Travel:
      
Primarily local travel to client sites in the Philadelphia metropolitan area (including northern New Jersey). This will be a hybrid role, involving remote work from a home office, regular presence on-site at our King of Prussia, PA office to support and collaborate with engineering teams, as well as ad-hoc travel to client sites in the surrounding areas. Specific requirements around remote work vs. presence at KOP office vs. ad-hoc travel to client sites will vary depending on assigned project work.
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring an Associate Process Engineer (Contract) on-site with our client in Princeton, New Jersey.
      
 
Primary Responsibilities:
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Support start-up of biotechnology, cell & gene therapy, and pharmaceutical manufacturing facilities
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Computerized Maintenance Management System (CMMS) implementation and qualification
  • Directly and/or indirectly perform project management roles for projects assigned within primary focus areas
  • Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables
 
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline
  • 1-3 years of experience in the biotech/biologics, cell/gene therapy, and/or pharmaceutical/drug sectors
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems
  • Direct or indirect experience with project management concepts and tools
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
Is Kymanox the right fit for you?
 
     You want to make a difference and have an impact…
     You enjoy having an influence in your day-to-day work…
     You are motivated by working alongside a team filled with
                  subject matter experts that will help you learn and grow…
     You wake up every day and do what you do
            … because patients deserve better.
 
If this sounds like you, you’ve come to the right place.
The Technical Proposal Specialist will join our Business Solutions and Marketing team and play a key role in supporting our Sales teams. The Technical Proposal Specialist will be primarily tasked with the development of sales proposals and statements of work. You will be working in a cross-functional setting across business development and account management to support the development of sales opportunities and ensuring scope, resourcing, and budget are accurately captured and presented to clients.
 
Responsibilities:
  • Author and/or revise proposals, statement of works, change orders, and related documents, as assigned.
  • Work with cross-functional team leads and sales representatives to ensure scope, budget, and resources align with client expectations and needs.
  • Support updates to the CRM for tracking proposal and opportunities with clients.
  • Support development and maintenance of database of proposals and offerings for functional service areas.
  • Support maintenance of templates and tools for authoring statements of work, proposals, change orders, and related documents.
  • Support development of processes and tools for improving efficiencies within the sales team.
  • Support development of client presentations and related sales and marketing information, as assigned.
  • Support development of materials for training team members on proposal process and proposal writing techniques.
  • Collaborate internally to help strengthen organizational processes to create and improve delivery efficiencies.
Experience:
  • The ideal candidate will have a bachelor’s degree in engineering or science with coursework or work-related experience in sales, business development, marketing, or communications. Advanced Degree (e.g., Masters, PhD) preferred.
  • 0 to 3 years of Proposal Writing or related experience, preferably in the Life Science industry. 
  • Experience with CRMs (e.g., Salesforce)
  • Knowledge of Technical Writing and CGMPs and drug/device development.
  • Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.
Desired Aptitude and Skill Set:
  • Detail-oriented
  • Strong organizational skills and verbal/written communication skills
  • Highly motivated self-starter with a sense of ownership and willingness to learn
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Ability to form partnerships with internal stakeholders
  • Seasoned soft skills (i.e., high EQ)
  • Technology savvy
 
Travel: 
Limited travel is possible for support at client meetings and related events. A passport is required for this job.
 
About Kymanox:
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride… because patients deserve better.    
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany and Switzerland.    
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.    
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Senior Manufacturing Quality Specialist to join our Quality Assurance and Compliance team and play a key role in supporting Kymanox’s clients with compliance activities, with an emphasis on QMS, audits, and gap assessments.  
      
 
Primary Responsibilities:
  • Quality oversight of suppliers (e.g., CMOs, CRS, laboratories, distributors, and specialty services providers), including day-to-day quality support of client programs.
  • Batch disposition and review of batch records, QC data, and supporting documentation.
  • Quality management system element support (e.g. deviations, nonconforming products, corrective and preventive actions, complaints, change management, supplier management).
  • Quality review of technical documentation and regulatory submissions.
  • Inspection readiness activities and participation in regulatory body inspections.
  • Supplier management activities, including audits of raw material and component suppliers, CMOs, CROs, laboratories, distributors, and specialty service providers.
  • Gap assessments against industry regulations or standards and remediation support.
  • Design and implementation of Quality Management Systems. Development of policies or standard operating procedures and training (internal and external).
 
Minimum Qualifications:
  • A bachelor's degree in a science-related or engineering discipline.
  • 7-9 years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sector.
  • 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.
  • Strong ability to drive program and project initiatives from the concept phase to full implementation.
  • Strong business acumen and ability to engage, build, and maintain strong client relationships.
 
Travel:
This role may require 10-20% remote travel domestically and internationally to Kymanox offices and client sites. A passport is required for this job.
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.
Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Quality Systems Specialist to provide direct operational support of the Quality Management System (QMS). The main objective of this role is to support senior Quality staff to effectively manage and maintain compliance of the QMS. 
      
 
Primary Responsibilities:
  • Support internal QMS initiatives, including eQMS administration and quality module implementation. 
  • Collaborating with cross-functional teams for establishing and maintaining QMS elements.
  • Manage and maintain QMS elements such as:
    • Deviation and CAPA
    • Change Control
    • Document Control
    • Training
  • Internal and External Audit support
  • Author, review, and approve QMS documents
  • Generate and perform QMS trainings
  • Assist with the generation of quality metrics
  • Other quality-supporting duties as required
 
Minimum Qualifications:
  • Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
  • Minimum 2 to 5 years of experience supporting a medical device and/or pharmaceutical QMS.
  • Previous experience with quality management software platforms.
        
___________________________________________________    
   
About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


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.