A leading organization in the field of cellular therapy is seeking a skilled individual to join our dynamic team as a CMC Lead. This pivotal role involves supporting U.S. regulatory activities pertaining to our cutting-edge cellular therapy programs, particularly focusing on spearheading the CMC product strategy for our innovative CAR T pipeline.
Responsibilities:
- Lead GMP-compliant manufacturing operations, overseeing technology transfer, process development, optimization, and GMP manufacturing.
- Ensure the development and optimization of robust and scalable CAR T manufacturing processes, emphasizing yield, purity, and product consistency.
- Maintain compliance with relevant regulatory guidelines, including those set forth by the FDA and other global health authorities.
- Collaborate effectively with cross-functional teams to align CMC activities with overall company objectives.
- Provide expertise in CMC for global development and registration programs, including INDs, CTAs, BLAs, and MAAs.
- Act as the primary regulatory representative for assigned projects, both internally and in meetings with regulatory agencies.
- Offer regulatory support for pertinent quality systems, such as change control, discrepancy management, and inspection management.
- Manage contract staff and vendors as necessary to support regulatory activities.
- Drive Process Development group goals and assist in managing project plans, timelines, and budgets.
- Establish the strategy and infrastructure for developing novel production processes for candidate engineered T cell therapeutics.
Benefits:
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
