Our client is an early stage medical device company that is revolutionizing care in the orthopedic field with their proprietary technology. They are hitting their stride nicely with excellent funding and investment players and clinical trial results that are laying the foundation for success.
This is a hands-on leadership role that requires working on-site in the laboratory including daily interaction with cross-functional team members from chemistry, bioengineering, preclinical, clinical, design, product development, and manufacturing. (During Covid, work on site will be about 60%.) Additionally, this high-visibility role will interact regularly with members of the executive committee, advisors and board of directors.
· Design, develop, build and qualify prototype, pilot, and full-scale manufacturing processes utilizing a Quality by Design approach as appropriate
· Act as a key technical resource for Manufacturing, from raw material management, to wet chemistry processes, inspection and packaging
· Lead the planning and coordination of all process development activities to launch and commercialize new products
· Lead the execution of validation projects and the collection of data to support completion of process validation activities
· Lead team members to develop and release product and process documentation including SOPs, Work Instructions and incoming inspection requirements
· Lead team members by example in promoting a positive, disciplined and scientific approach to process development
· Maintain good documentation practices for GMP compliance
· BS in Chemical Engineering, advanced degree preferred
· 10+ years of industry work experience required, including people management
· Experience in medical device process development, technology transfer, validation and GMP manufacturing required (experience in biotech or pharmaceutical process development will be considered)
· Experience working in ISO 13485/GMP manufacturing and clean-room manufacturing/process environment preferred
· Experience include polymer processing, operation of controlled mixing processes, operation of controlled motion, temperature and pH systems, device sterilization, sterile filtration and wet packaging preferred