Describe the primary goals, objectives or functions or outputs of this position.
Contribute to process validation activities and guide strategy for process development to support regulatory approval of biologics. Independently author process-related regulatory documentation. Independently conceive, execute, and communicate novel ideas to improve process development and validation strategy to achieve project and area goals. Contribute to CMC project management and serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.
- Guide process development strategy for internal programs and external collaborations to ensure cross-functional alignment and delivery of comprehensive development package. Provide guidance for cell culture and purification process characterization, applying QbD principles.
- Contribute to process validation activities, including strategy development and validation documentation.
- Primary author of regulatory documents, including INDs, BLAs, briefing packages, and responses to regulatory inquiries.
- Manage and drive project timelines to ensure successful process validation, regulatory submission, and launch.
- Apply manufacturing process technical knowledge to support problem-solving during process development and validation.
- Guide and mentor scientific personnel to support area goals and team development.
- Independently responsible for project science within her/his area of expertise on one or more project teams.
- Generate new scientific and capability development proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
- BS in engineering or scientific discipline or equivalent education and 12+ years of experience; MS in engineering or scientific discipline or equivalent education with 10+ years of experience; PhD in engineering or scientific discipline with 4+ years of experience.
- Demonstrated broad knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development from early development through commercialization.
- Experience leading biologics manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
- Experience leading and guiding process validation activities including development of validation strategy, authoring of validation documentation, validation activity support, and troubleshooting.
- Demonstrated knowledge scientific and regulatory requirements and strategy for phases of development from early development through post-approval management.
- Demonstrated outstanding writing and technical communication skills, including experience authoring validation and regulatory documentation.
- Demonstrated creative 'out of the box' thinking to solve difficult technical problems and champion new technologies/approaches to achieve project goals.
Significant Work Activities: N/A
Travel: Yes, 50 % of the Time
Job Type: Experienced