In this role, you would lead process validation activities and drive validation timelines. Independently conceive, execute, and communicate novel ideas to improve validation strategy to achieve project and area goals. Provide technical input to validation-related activities to enable regulatory submission and author sections of regulatory documents. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.
- Lead process validation activities and drive validation timelines to meet project goals.
- Independently conceive, execute and communicate novel ideas to improve validation strategy.
- Author process validation documentation, including process validation master plan, process performance qualification protocols and reports.
- Author sections of regulatory documents, including INDs, BLAs, briefing packages and responses to regulatory inquiries.
- Provide technical input to validation-related activities to enable robust regulatory submission, including areas of process development, process characterization, tech transfer and process validation.
- Support process development strategy for internal programs and external collaborations to ensure cross-functional alignment and delivery of comprehensive development package.
- Apply process technical knowledge to support problem-solving during process development and validation.
- Serve as a lead scientist within his/her own project and provide technical expertise on one or more project teams.
- Lead group initiatives to improve workflows and aid program acceleration.
- BS or equivalent education in Biochemistry or Chemical Engineering and 10+ years of experience; MS or equivalent education in Biochemistry or Chemical Engineering with 8+ years of experience, PhD in Biochemistry or Chemical Engineering with 0 to 2 years of experience.
- Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
- Experienced supporting manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
- Experienced authoring validation documentation, validation activity support, and troubleshooting.
- Demonstrated knowledge of scientific and regulatory requirements for implementation of post-approval process changes.