Principal Process Development Engineer – Pharma/Device Manufacturing – RTP, NC / Top $$
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 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.