Principal Product Development Engineer/ Scientist
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 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 or Scientist with a 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, expertise, 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:
- Evaluate client technical documentation and development strategy to provide clear, actionable recommendations for mitigation(s) of challenges.
- Develop detailed project plans, schedules, and overall project strategy.
- Oversee phase-appropriate client testing activities, including combination product and 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
- Lead and/or oversee the creation of technical documentation supporting product development efforts.
- 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
- Ability to think strategically
- 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:
- Minimum 15 years' experience (including advanced degrees) in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.
- Leadership of complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.
- Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.
- Management of direct reports is not in scope of this role at the time of hire. However, organizational growth may allow for the role to expand to managerial responsibility of 1-5 direct reports. Successful candidates for this position will be experienced in leading and mentoring junior staff.
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.
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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 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.