This is a senior engineer position within the CAR T technical transfer & clinical manufacturing support group. The position will lead the technical transfer of the new pipeline products from Research/Development to Clinical Manufacturing within Celgene Cell Therapy Development Organization. This role is also responsible for manufacturing support, personnel training, writing procedures/protocols/reports, trending manufacturing data and leading manufacturing troubleshooting. Activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures. The qualified candidate should have extensive work experience in process development for cell therapies/biologics, strong knowledge in cGMP of cellular products/biologics and a solid understanding of the fundamentals of tech transfer, process development & characterization, and manufacturing science.
Responsibilities will include, but are not limited to:
- Lead process transfer from Research/Development to Clinical Manufacturing.
- Write & review procedures, protocols, and reports.
- Work as a process SME to support clinical manufacturing, troubleshooting, deviation investigations and identify appropriate CAPAs.
- Perform manufacturing data trending to contribute to the lifecycle management of a process.
- Author & review IND documents and provide necessary technical input to support regulatory discussions.
- Support process changes during the lifecycle.
- Train end-users and entry-level personnel on the manufacturing process.
- Interact with other CMC teams, Quality Operation, Clinical Operation, Regulatory, Facility and other personnel as dictated by project needs. Contribute in a team-oriented environment to achieve common project goals.
- Maintain knowledge of scientific literature & regulatory guidelines and apply key concepts to project activities/plans.
- Ph.D. in Biochemical Engineering or related discipline with 3+ yrs process development experience, or MS with 8+ yrs, or BS with 10+ yrs process development experience for cell therapies or biologics.
- Strong grasp and application of engineering fundamentals pertaining to immunotherapy process development.
- Experience with GMP manufacturing.
- Knowledge of GLP, GCP, ICH and FDA guidelines related to cell therapies/biologics.
- Excellent organization, verbal and written communication and presentation skills.
- Ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationships.
- Ability to work independently.
Application procedure: To apply, please send your cover letter and CV/resume to Greg Russotti (firstname.lastname@example.org)
Location: Warren, NJ