Manager, Science & Technology - CAR-T
Other Locations:US- NJ- Warren
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Manager, Science & Technology - CAR-TWarren, NJ
We seek a highly motivated manager with demonstrated expertise in cell therapy development to driving technical transfer & validation activities that support rapid commercialization of CAR T therapies. The qualified candidate will be responsible for managing the analytical transfer of CAR T technology to CMOs, in US, EU or Japan to ensure timely manufacturing readiness. Additionally, this position is responsible for managing the development, qualification, and validation of analytical methods at CMOs and preparing validation packages for commercial registration filing (BLA/MAA/J-NDA). The successful candidate will also be required to review documents for regulatory submissions (IND/CTA/J-CTN & BLA/MAA/J-NDA) and provide technical input to regulatory discussions in US, EU & Japan. Significant technical expertise in analytical method development and strong project management skills are required for this position. This role will also involve extensive interaction with Celgene collaboration partners' technical transfer teams and collaboration within cross-functional Celgene teams.
Responsibilities will include, but are not limited to:
- Manage the development, optimization, qualification and validation of analytical methods at CMOs.
- Manage analytical transfer efforts and drive the execution plan of analytical transfer activities and manage timelines & deliverables for analytical transfer.
- Ensure method qualification, method transfer, and analyst training to meet company and regulatory requirements.
- Review technical documents, including study protocols, study reports, batch records, SOPs, analytical transfer protocols and reports etc. to ensure the analytical readiness at CMOs.
- Assist CMOs in the development of analytical qualification and validation plans.
- Assist CMOs in preparing various analytical validation protocols & reports.
- Participate in key analytical transfer & analytical validation activities at CMOs.
- Review analytical validation reports & ensure the quality of the validation data packages in support of commercial registration filing.
- Provide technical support to mock PAI inspections at CMOs.
- Assist CMOs in preparing for commercial launch.
- Review regulatory documents for IND/CTA/J-CTN & BLA/MAA/J-NDA filings.
- Provide necessary technical input to support regulatory discussions in US, EU & Japan.
- Serve as an analytical SME from CMC in cross-functional teams and support execution of process operational strategies.
- Build on experience and adapt approaches to expand and develop operations as the program extends into Europe and Asia-Pacific.
- PhD in biological science, biomedical/chemical engineering, or related discipline with minimum 3 yrs of pharmaceutical laboratory experience required, or MS with 8 yrs, or BS with 10 yrs of pharmaceutical laboratory experience preferred.
- Solid understanding of the fundamentals of analytical development & qualification, and analytical transfer.
- Knowledge of cGLP/cGMP, quality system and risk management.
- Experience with flow cytometry (immunophenotyping), in vitro T cell functional assays (intracellular staining, proliferation, cytotoxicity, multiplex ELISA platforms), PCR, cell counting is required.
- Experience with sterility, endotoxin and mycoplasma testing for cellular product is a plus.
- Hands-on proficiency with analytical methods and instrumentation.
- Knowledge of human T cell immunology and development of genetic modified T cells.
- knowledge of USP and other compendia as well as FDA, EMA and ICH guidance on product release testing, raw material testing and analytical method validation.
- Ability to work independently.
- Ability to work in cross-functional teams efficiently and interacting with external collaborators to build strong relationship.
- Excellent organization, verbal and written communication and presentation skills.
- Strong technical writing skills.
- Ability to develop and drive project plan and timeline and deliverables to meet overall project goals.
- Experience with assay validation highly desirable.