Job Title: Senior Engineer, Process Sciences
Location: Poway, CA
We are working with a leading innovator in regenerative medicine. Our client is looking for a Senior Engineer to join their Process Sciences team. This is an exciting opportunity to play a key role in developing and improving process control strategies for cutting-edge biologic products, with a focus on clinical manufacturing and process characterization.
As the Senior Engineer, you will collaborate closely with cross-functional teams, taking ownership of key manufacturing processes and providing technical support for GMP operations. This role is perfect for someone with strong experience in cGMP manufacturing, process validation, and tech transfer for biologics.
Key Responsibilities:
- Develop and continuously improve process control strategies for novel regenerative medicine products.
- Lead process risk assessments, characterization experiments, PPQ execution, and continued process verification (CPV).
- Build and maintain a comprehensive database of manufacturing operations to support cross-functional teams.
- Provide rapid data tabulation, statistical modeling, and trending for batch reviews.
- Own and close out quality systems records (deviations, CAPAs, change controls) in a timely manner.
- Provide technical support for GMP compliance, addressing issues and escalating critical matters as needed.
- Generate protocols and technical reports related to process characterization and regulatory filings.
- Support tech transfer activities and oversee on-site vendor activities, including PPQ oversight.
Qualifications:
- Bachelor’s degree in Cell Biology, Chemical Engineering, Biomedical Engineering, or a related field (advanced degree preferred).
- Minimum of 5 years of experience supporting process development, tech transfer, and cGMP manufacturing of biologic drugs.
- Strong understanding of cell culture, purification, and fill/finish operations.
- Hands-on experience with adherent cell culture operations, aseptic technique, and TFF systems.
- Experience with Quality by Design (QbD) principles and statistical tools like JMP is a plus.
