We are looking to an experienced Senior Process Development Engineer to join our client located in the Raleigh-Durham area in North Carolina. You will be responsible for supporting process development and leading process optimization, scale-up and validation for drug products from early through late-stage development and commercial release.
Responsibilities:
- Leading development, tech transfer, and qualification of manufacturing processes for sterile drug products used in non-clinical and clinical development
- Supporting operations, maintenance, and GMP facility development for ISO 7/8 clean room
- Leading process optimization and validation of manufacturing processes
- Collaboration with Formulation, QA, Regulatory, and Analytical teams at external manufacturing sites (CDMOs)
- Lead late stage process optimization and validation activities
- Verify clean room operating conditions for sterile products & maintain documentation
Qualifications:
- 5 years of relevant industry experience with advanced degree, OR B.S. with 7+ years of relevant industry experience in a GMP environment
- Strong knowledge of small molecule drug process development
- Hands on experience using hot melt extrusion, injection molding or materials characterization equipment is a plus
The expected salary range for this role is between $120,000 and $145,000 with an annual bonus based on performance.
