Principal Product Development Engineer/ Scientist

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 in