Work Location: Houston/Bellaire, Texas, United States
Job Category: Professionals
Organization: Biotech/Pharma
Employee Status: Full-time
Job Type: Full-time, Exempt
Essential Roles and Expectations
The individual will coordinate the technology transfer and oversee the contracted manufacturing of the company’s CAR-T portfolio. This position will focus on CMC project management in support of CAR-T cell therapy clinical trial from early-phase to the pivotal study. The individual will actively interact with internal CMC team and external SMEs during the tech transfer and manufacturing implementation for autologous CAR-T products. The ideal candidate for this position should have hand-on experience in manufacturing of CAR T cells, strong knowledge in GMP and ICH/FDA/EMA guidance for Cellular and Gene Therapy Products, exceptional expertise in advanced manufacturing technologies and analytical methods. The individual is expected to have a solid understanding of the fundamentals of tech transfer, project management, risk assessment, and GMP manufacturing.
Additional responsibilities include but are not limited to the following:
- Take a lead role in a cross-functional team to manage daily GMP manufacturing at the CDMO sites
- Lead project team in production planning, material/product shipment tracking, and vendor management
- Provide technical support and lead troubleshooting for CDMO manufacturing and QC testing
- Track the clinical manufacturing batch records, testing reports, product release, and supply chain
- Assist internal SMEs in investigating deviations, OOS, and other quality issues reported by CDMO sites
- Work effectively as a technical liaison to support project team to meet project timeline and objectives
- Write and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations.
- Create and maintain the database of MBR, SOPs, and other manufacturing relevant documents
· Coordinate the training of end-users and entry-level personnel on the manufacturing process.
· Maintain knowledge of scientific literature & regulatory guidelines and apply key concepts to project activities/plans.
· Assist executive in developing corporate strategy for external contracted manufacturing in North America and Europe
Qualification
· Ph.D. in Cell Biology, Immunology or related discipline with 3+ yrs manufacturing experience, or MS with 5+ yrs manufacturing experience, or BS with 8+ yrs manufacturing/PD/MSAT experience of cell therapy products including at least 2 years industry experience of CAR T cell manufacturing/PD/MAST.
- Knowledge in T-cell biology and immunology are required
- Strong technical knowledge in manufacturing process of autologous cell therapy products and virus-based products is required
- Previous leadership experience is required
- Previous experience in process development, process validation and regulatory filing are preferred
- Familiarity with analytical methods typically used in the manufacture and characterization of IPC and final CAR T cell product is preferred
- The ability to analyze data and present findings to management is required
- Experience with team-based collaborations or direct management of staff is required
- Excellent in self-motivation and time management
- Occasional domestic or international travel will be required
CARsgen Therapeutics is a privately held, clinical stage immune-oncology biotech company. The company’s leading programs set it apart from other CAR-T company by focusing on the development novel therapies for solid tumor treatment. CARsgen received FDA clearance of the first CAR-Claudin18.2 T cell therapy for advanced gastric and pancreatic cancer. At present, CARsgen has two ongoing phase 1 clinical trials in North America and four Phase 1 clinical trials in China. The company will provide its employee a very competitive compensation plan, including base salary, 401K, insurances, equity option, bonus, PTO, etc.