Sr/Principal Engineer, R&D Manufacturing (Device/Sterile Products) – RTP/Top $$

Job Type: 
Scientific Research and Lab Operations
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a rapidly-expanding RTP-based company that is developing a highly anticipated portfolio of aseptically manufactured products, is actively recruiting for an exceedingly skilled Manufacturing Engineer to assume a key role leading all manufacturing efforts in its GMP-compliant facility.  

Products include devices, combo products and pharma products, and exposure to all would be valuable.  Company will pay absolute top dollar to attract and retain a star.

Key things to note:

  • This company boasts a rich pipeline, and this Manufacturing Engineer will lead the transition of product manufacturing processes from development through process optimization and scale-up.   Substantial experience manufacturing sterile products will be essential.

  • These are extended release products, some implanted.  Experience driving manufacturing from preclinical through phase 3 will be important.  Extended release and/or implanted products/devices highly preferred.

  • Most products are manufactured in its RTP-based facility.  Seek candidate skilled in running a GMP-compliant operation.  Expertise in CFR Parts 210 and 211 required.  Some manufacturing is done at its European facility and/or thru CMOs.  Experience overseeing off-site manufacturing also  important.

  • The company is experiencing tremendous growth.  All policies and procedures are being developed and/or enhanced.  “Builder mentality” will be essential.  Experience planning the opening/expansion of a cGMP facility is highly preferred.

  • This is a highly collaborative role.  This Principal Engineer will be the Subject Matter Expert who leads cross-functional teams to shared success.  Right candidate will complement broad and deep technical credentials with exceptional project leadership and process management.

Specific duties will include:

  • Develop manufacturing plans for extended release and device products from early development through commercialization.  Ensure compliance with GLP and cGMP standards

  • Lead development, tech transfer, and qualification of manufacturing processes for products

  • Oversee material sourcing, management, and distribution of processing/manufacturing equipment, APIs, excipients and packaging

  • Develop Standard Operating Procedures (SOPs), Installation/Operational/Performance Qualification (IQ/OQ/PQ) Protocols and Reports, and Batch Production documents for development and manufacturing activities

  • Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)

  • Take a leadership role in the development of raw material specifications, product specifications and shelf-life estimates

  • Write, review and approve of Chemistry, Manufacturing and Controls (CMC) documents, including development protocols and reports, including regulatory submissions

  • Create and review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time and within budget

  • Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals.  Ensure timely, thorough and accurate communications

  • Help ensure overall operational spend is within the approved budget and timeline

Targeted candidate will offer an Engineering degree and 8+ years of cGMP drug and/or implantable medical device experience, with particular experience in sterile product manufacturing.  Knowledge of CFR Parts 210, and 211, ICH and FDA regulatory guidance assumed and required.  Other priorities include:

  • Substantial experience manufacturing clinical supplies

  • Process development/manufacturing for extended-release dosage forms or devices.  Familiarity with implants, drug eluting stents, and/or polymer processing preferred

  • Scale up and tech transfer

  • Process optimization

  • Strong writing skills, including SOPs and CMC documents

  • Demonstrated ability to engage and lead cross-functional teams

  • Longevity and impact in previous roles

Finally and critically, we seek a forward-thinking quick study who will thrive in this emerging and collaborative setting; an innovative, process improvement-focused candidate who will have significant impact.  The future is very bright. We seek a leader who will contribute and thrive.

Compensation will be generous and include an industry-leading base, bonus, benefits and stock.  Please forward resume for prompt consideration. Local candidates only.