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 adding a Switzerland or Germany based Business Development Manager to our team to help grow and expand our EU client base and sales. Ideal candidates will have experience as an Engineer or similar role within the Medical Device, Cell and Gene Therapy, Pharma, or Biotech industry. 


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.

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.
• Help draft proposals/solutions for project opportunities and define outline of SOW.
• 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.
• 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.
• Keep CRM (SFDC) updated with all lead and opportunity information.

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.
• Experience developing new relationships & cross-selling current accounts.
• Previous experience with a CRM (Salesforce) preferred.
• Experience with MS Office products (Outlook, MS Teams, Excel, PowerPoint) required.

Desired Aptitude and Skill Set:

• Proven ability to provide consultative sales, and the ability to demonstrate your sales performance.
• 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
• 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.

Location:  Candidates must be based in the greater Munich area Germany or Basel, Burn, or Lucerne Switzerland.

___________________________________________________

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 adding a Switzerland or Germany based Business Development Manager to our team to help grow and expand our EU client base and sales. Ideal candidates will have experience as an Engineer or similar role within the Medical Device, Cell and Gene Therapy, Pharma, or Biotech industry. 


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.

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.
• Help draft proposals/solutions for project opportunities and define outline of SOW.
• 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.
• 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.
• Keep CRM (SFDC) updated with all lead and opportunity information.

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.
• Experience developing new relationships & cross-selling current accounts.
• Previous experience with a CRM (Salesforce) preferred.
• Experience with MS Office products (Outlook, MS Teams, Excel, PowerPoint) required.

Desired Aptitude and Skill Set:

• Proven ability to provide consultative sales, and the ability to demonstrate your sales performance.
• 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
• 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.

Location:  Candidates must be based in the greater Munich area Germany or Basel, Burn, or Lucerne Switzerland.

___________________________________________________

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 adding a Northeastern (Boston area preferred) based Business Development Manager to our team to help grow and expand our US client base and sales. Ideal candidates will have experience as an Engineer or similar role within the Medical Device, Cell and Gene Therapy, Pharma, or Biotech industry. 

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.

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.
• Help draft proposals/solutions for project opportunities and define outline of SOW.
• 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.
• 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.
• Keep CRM (SFDC) updated with all lead and opportunity information.

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.
• Experience developing new relationships & cross-selling current accounts.
• Previous experience with a CRM (Salesforce) preferred.
• Experience with MS Office products (Outlook, MS Teams, Excel, PowerPoint) required.

Desired Aptitude and Skill Set:

• Proven ability to provide consultative sales, and the ability to demonstrate your sales performance.
• 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
• 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.

Location:  Candidates must be based in Northeast area of the US, preferably the Boston area but open others.

___________________________________________________

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.

Kymanox is growing and looking for an experienced Sterilization Process Engineer to join our team based in our King of Prussia location!
(Open to remote US based candidates for the right fit)

The Senior Process Development Engineer will work alongside a cross functional team to support our customers in the development and validation of sterilization and disinfection processes. This engineer will direct, advise, and/or execute sterilization process development and qualification activities through collaborative engagements with clients, sterilization processing sites, and microbiological test labs. The Senior Process Development Engineer will execute tasks that may include:

· Analytically assess medical and pharmaceutical products for sterilization feasibility, including determination of most appropriate sterilization mode & method

· Develop sterilization validation plans in conformance with international standards and US/Europe regulatory guidance

· Plan, draft protocols, review results, and/or draft reports for sterilization process definition and/or process optimization studies

· Plan, draft protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance with international standards and US/Europe regulatory guidance

· Assess material compatibility, either analytically or experimentally, for sterilization processes

· Establish procedures and documentation for sterilization routine processing

· Work with microbiological test labs to establish/review/revise microbiological test methods and review test results

· Select and/or design sterile packaging for products

· Plan, draft protocols, review results, and/or draft/review reports for sterile packaging qualification and sterility maintenance verification

· Perform analytical assessments to inform design directions as needed.

· Work with cross-functional teams within the organization and with clients and external vendors (sterilization processing sites and microbiological test labs)

· Periodically participate in strategic planning activities.

Desired Aptitude and Skillset:

· Ability to translate sterilization ISO standards and regulatory guidance into specific procedures and tests for a range of medical and pharmaceutical products

· Ethical, responsible, and data-driven decision-maker

· 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

· Familiarity with Statistical Process Control (SPC), Lean, Six Sigma knowledge, a plus

· PC skills - MS Office Suite required.

Educational Background:

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

Experience:

· Minimum of 5 years of relevant experience in sterilization, sterile packaging and/or microbiology

· Direct experience in new process development and validation for at least two of common sterilization methods (such as: EO, gamma/x-ray irradiation, e-beam irradiation, steam heat, dry heat, hydrogen peroxide, etc.)

· Detailed familiarity with key ISO standards for sterilization, such as ISO 11135, 11137, 17665, 14937

· Strong leadership and project management skills with proven track record within testing and validation.

· Knowledge of design controls.

· Proficiency utilizing MS Office Suite (Word, PowerPoint and Excel etc.), and statistical software tools such as Minitab for data analysis or experiment design

____________________

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.

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.

Job Description

Kymanox is adding an RTP based Business Development Manager to our team to help grow and expand our US client base and sales. Ideal candidates will have experience as an Engineer or similar role within the Medical Device, Cell and Gene Therapy, Pharma, or Biotech industry. 


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.

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.
• Help draft proposals/solutions for project opportunities and define outline of SOW.
• 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.
• 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.
• Keep CRM (SFDC) updated with all lead and opportunity information.

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.
• Experience developing new relationships & cross-selling current accounts.
• Previous experience with a CRM (Salesforce) preferred.
• Experience with MS Office products (Outlook, MS Teams, Excel, PowerPoint) required.

Desired Aptitude and Skill Set:

• Proven ability to provide consultative sales, and the ability to demonstrate your sales performance.
• 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
• 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.

___________________________________________________

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.

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

__________________________________

Is Kymanox the right fit for you?

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

___________________________________

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

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.

Reporting to the Director of Regulatory Affairs, the Principal Regulatory Affairs Advisor will lead Kymanox’s regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory submissions covering medical devices, drug products, biologics, and combination products. This person will be supported by experienced technical project managers and drug and device development professionals while working with clients. This position involves high-level strategic planning as well as hands-on responsibilities.

Projects may include the following focus areas:

• Regulatory Submission Authorship and Review
• Device/Drug/Combination Product Development Strategy and Commercialization Strategy
• Labeling review
• Nonclinical toxicology strategy
• Clinical strategy design and clinical protocol authorship
• Design Controls and Design Change Management
• Gap assessments of technical documentation and regulatory submissions

Responsibilities

• Prepare US and EU regulatory submissions (IND/NDA/BLA/IDE/510k/PMA/technical documentation/drug dossier), meeting briefing books, clinical trial applications, and annual reports for regulatory authorities.
• Lead and attend meetings with regulatory authorities.
• Perform technical and regulatory review of source documents.
• Review and edit dossiers, briefing books, and responses to health authority questions; work with SMEs and authors to prepare information for submissions and ensure submission readiness.
• Participate in product development teams as regulatory SME.
• Conduct gap assessments of regulatory submissions, clinical data, nonclinical data, design history files, and other technical documentation against industry regulations and standards (US/EU/ROW).
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Review combination product development process documentation including formulation development reports, batch records, toxicology reports, clinical study reports, user requirements, technical design requirements, product risk management (including user FMEA, risk management reports) documents, verification and validation test protocols; and communicate any regulatory-specific red flags during review
• Provide assessment of regulatory impact of changes to on market products.

Desired Aptitude and Skill Set

• Demonstrated experience of preparing US FDA/EU EMA submissions (eg, IND/NDA/IDE/510(k)/PMA/BLA)
• Working knowledge of Quality System requirements (FDA Part 820, Parts 210/211, Part 4, and ISO 13485)
• Working knowledge of ICH guidelines for CTD, GMPs, clinical, nonclinical and pharmaceutical quality requirements
• Working knowledge of design controls (FDA 21 CFR 820.30)
• Working knowledge of device risk management (ISO 14971)
• Working knowledge of EU medical device and medicinal product regulations
• Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
• Highly organized
• Resourceful, Self-directing, self-pacing, fast learner
• Excellent analytical and communication skills, particularly writing skills, are essential
• Pleasant and positive communication style

Educational Background

• Bachelor’s or Master’s degree in regulatory affairs or science-related discipline or engineering from an accredited institution; PhD is preferred
• Industry certifications (e.g., RAC, ASQ) are a plus

Experience

15+ years of regulatory experience in the US medical device, pharmaceutical, or combination products industry (this includes post graduate experience)

Travel: 

Local travel within the assigned region and surrounding areas is required.  Up to 30% domestic and international travel may be required from time to time.  The intent of this position is to stay local in the assigned region; however, the best project and growth opportunities may require initial travel to establish yourself and/or the firm with the client.  If not located near Kymanox Headquarters, quarterly visits to RTP, North Carolina are expected.

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.

Kymanox is growing and looking for a Contract Lab Technician to join our team in our Neuma by Kymanox team in King of Prussia location!

__________________________________

Is Kymanox the right fit for you?

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

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Primary Responsibilities:

· Perform testing in accordance with established protocols to support method validation and design verification

· Perform data analysis and some troubleshooting

· Maintain laboratory equipment and supplies

· Prepare and maintain laboratory records

· Communicate effectively with all team members

· Follow all safety procedures

Minimum Qualifications:

· Degree in a scientific, engineering, or other technical discipline, Bachelor’s preferred

· Good understanding and compliance with principles of Good Documentation Practices

· Familiarity with CGMP

· Experience in a laboratory setting

· Strong organizational and time management skills

· Excellent attention to detail

· Thrive when working independently and as part of a team

Preferred Qualifications:

· Familiarity with medical device/combination product testing

· Experience working within a quality system

· Familiarity with deviation and non-conformance investigations

· Demonstrated work ethic and accountability

· 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.

Kymanox is hiring an additional Regulatory Scientist to help prepare high quality documentation for regulatory submissions to help streamline the regulatory approval process for our clients. The Regulatory Scientist is a major contributor to document authorship for a variety of regulatory and clinical documents across different therapeutic areas. The Regulatory Scientist will work closely with the regulatory affairs project lead and interface directly with the client.

Responsibilities

• Work closely with client and internal organization teams to develop and prepare regulatory documents
  
  
  
• Author documents per client specifications, templates, style guides, and other guidance documents
  
  
  
• Author documents per regulatory authority guidelines and requirements and as guided by regulatory strategies provided by the Kymanox Regulatory team
  
  
  
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
  
  
  
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
  
  
  
• Maintain collaborative, proactive, and effective communication with both client and internal teams
  
  Qualifications

• Bachelor’s degree; MS or PhD preferred

• 3+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as:

• 5 Clinical Overview
• 7 Clinical Summaries
• Clinical Study Reports
• Clinical Study Protocols
• Briefing Documents

• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
• Experience in the development of submission-level documents (does not require functioning as a document lead)

Skills & Abilities:

• Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Experience with using reference manager software and eCTD formatting
• Strong understanding of the document creation process and of the drug development lifecycle
• Able to synthesize data across multiple data sources and documents to create summary reports, including published literature
• Expertise to provide quality document preparation, document review, accurate comment resolution/incorporation, and document finalization
• Ability to own submission-level sections (e.g., clinical section [Module 2.7], nonclinical section [Module 2.6]), taking responsibility for clarity of purpose
• Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
• Possesses broad experience and technical expertise across more than one therapy area and integrates this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization
• Experience planning and executing internet literature searches using databases such as PubMed, Embase

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 in King of Prussia, Pennsylvania.

Kymanox is hiring an additional Account Manager to our growing Business Development team in the RTP area.

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 role work…
• You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow…
• You wake up every day and do what you do

… because patients deserve better.

If you’ve checked these boxes, you’re in the right place.

Job Description:

The Account Manager will join a key role within our Business Development team. The Account Manager is primarily tasked with assisting the organization with the achievement of revenue goals and client satisfaction objectives. As the Account Manager, you will manage the continued growth and success of our client partnerships by ensuring outstanding service and delivery in support of our clients’ programs. You will also be responsible for identifying and helping to close new business and work in a cross-functional setting across business development, business services and project management teams.

Responsibilities:

• Write proposals/solutions for project opportunities.
• Directly manage a primary set of accounts in the Life Science industry.
• Follow up on warm leads to convert into new business.
• Coordinate and execute a plan for the increased use of the company’s services at the client by building relationships with a strong account plan.
• Align closely with the Project Management team to deliver excellent customer service and overall client satisfaction.
• 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 for assigned client accounts.
• Create and deliver quarterly client presentations, including quarterly business reviews and action plans.
• Support our Business Development team to identify opportunities and secure renewals for assigned clients.
• Work closely with Business Development and Operations teams to accurately forecast and recognize client revenue.
• Collaborate internally to help strengthen organizational processes to create and improve delivery efficiencies.
• Attend events and conduct lead generation campaigns to discover project opportunities.
• Keep CRM updated with all lead and opportunity information.

Required Educational Background:

Bachelor’s degree preferably with a STEM degree (Science, Math, or Engineering) from an accredited institution.  

Experience:

• The ideal candidate will have 5+ years of experience in Account Management, Business Development or a comparable Client Services role.
• Experience in the Life Sciences industry.
• Previous experience with a CRM (preferably NetSuite).
• 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
• Excellent problem-solving skills
• 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 40% remote travel domestically and internationally is possible. A passport is required for this job.

 
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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 ResearchTriangle 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.