This is an engineer/scientist position within the CAR T technical transfer & clinical manufacturing support group. The position will be responsible for the process 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 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:
- Perform 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.
- B.S. in Biochemical Engineering or related discipline with 7+ years, or MS with 4+ yrs of process development experience for cell therapies or biologics.
- Strong grasp and application of engineering fundamentals pertaining to immunotherapy process development.
- Experience working in a GMP regulated environment. Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines related to cell therapies/biologics.
- Ability to work with minimal technical supervision and perform operational tasks independently.
- Strong verbal and written communication skills and interpersonal skills.
- Highly motivated and driven to acquire new skills.
Application procedure: To apply, please send your cover letter and CV/resume to Greg Russotti (email@example.com)
Location: Warren, NJ