Job Description

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 who 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.

Responsibilities:

• Directly support and provide subject matter expertise related to CMC/Pharmaceutical Development, Analytical Sciences, Quality Control, Stability, and Product/Process Scale-up related projects.
• Perform project management roles for projects assigned within primary focus areas of CMC Services and Analytical Sciences.
• Author, format, and review CMC/Quality Sections of INDs, NDAs, ANDAs, BLAs for Regulatory Submission.
• Author, format, and review technical protocols and reports covering analytical method validation, method transfer, stability, tech transfer, risk management documentation, and process qualification.
• Validated various pieces of equipment to be commissioned in a GMP environment.
• Regulatory document drafting for biologics, small molecules, and drug-device combination products (DHF creation, DHF remediation, ICH/FDA process risk assessments, etc.).
• Quality compliance support (deviation investigations, change control coordination, complaint investigations, etc.).
• Control system validation support.
• Developed Assay, Impurity, and RS methods for use by HPLC for the CDMO clients.
• Conducted validations and transfers of HPLC methods.
• Performed release and stability sample testing for internally manufactured and client provided samples under GMP/GLP specifications.
• Wrote reports, SOPs, change controls, and protocols for internal and external use.

Educational Background:

• The ideal candidate will have a bachelor’s degree in engineering or science with coursework or work-related experience in GMP Analytical expertise

Experience:

• 5 to 7 years of working in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
• Demonstrated level of experience in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
• Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination product platforms is desired.
• Familiarity with risk management tools and applications as well as data analysis tools and applications.
• Understanding of ISO 13485 and FDAs QMSR.

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:

Up to 10% travel is possible.

Compensation:

Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.

About Kymanox:

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

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

To learn more about our company, please visit our website: Life Science Solutions | Kymanox

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.