We seek a highly motivated Scientist with demonstrated expertise in Stem Cell therapy development to driving tech transfer, process characterization & validation activities to support rapid commercialization of cell therapy products. The qualified candidate will be responsible for managing process transfer of cell therapy processes to CMOs in US & EU to ensure timely manufacturing readiness.
The successful candidate will also be required to review regulatory documents for submissions & provide technical input to regulatory discussions. Significant technical expertise in cell therapy process development & strong project management skills are required for this position. This role will also involve extensive interaction with collaboration partners, technical transfer teams & collaboration within cross-functional teams.
The preferred location for the position is New York City.
- Provide necessary technical & Laboratory support to process Development team; Act as Person-In-Plant (PIP) for development & Manufacturing activities
- Lead development activities with experience (strongly preferred) in the following areas:
- Immune cell or hematopoietic cell product development
- Platforms for characterizing immune cells
- Platforms & technologies for immune cell selection & isolation
- Managing cell therapy process development at CRO/CDMOs.
- Serve as a process SME from CMC in cross-functional teams & support execution of process operational strategies.
- Design (DOE), plan, & execute process development experiments & troubleshoot existing protocols to increase process performance as measured by efficiency, process robustness & final product yield.
- Oversight on development of assays at CDMO towards characterizing edited populations of HSCs
- Interact with other CMC teams, Quality Operation, Clinical Operation, Regulatory & other personnel as dictated by project needs. Contribute in a team-oriented environment to achieve common project goals
- Maintain knowledge of scientific literature & apply key concepts to project activities/plans.
- Manage process transfer efforts & drive the execution plan of process transfer activities & manage timelines & deliverables
- Review technical documents, including study protocols, study reports, batch records, SOPs, etc. to ensure the process readiness at CMOs.
- Assist CMOs in the development of process transfer, qualification & validation study plans.
- Assist CMOs in preparing various process related protocols & investigations.
- Participate in key tech transfer & process validation activities at CMOs.
- Review regulatory documents for BLA/MAA filings.
- Provide necessary technical input to support regulatory discussions in US & EU
- Ph.D. in Biochemical Engineering or related discipline with 3+ yrs. process development experience, or MS with 5+ yrs., or BS with 8+ yrs. Process development experience for Cell therapies is highly preferred.
- Strong grasp & application of engineering fundamentals pertaining to Cell Therapy process development, specifically on stem cell therapy
- Experience with process development, tech transfer activities
- 30% Travel
- In-depth knowledge & technical expertise in process development for cell therapies or, biologics.
- Strong knowledge in cGMP of cellular products or biologics
- Solid understanding of the fundamentals of process development, tech transfer & validation.
- Excellent organization, verbal & written communication & presentation skills.
- Ability to work in cross-functional teams effectively & interacting with external collaborators to build strong relationship.
- Ability to work independently.
- Ability to develop & drive project plan & timeline & deliverables to meet overall project goals.
- Experience in project management.