Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for drug product process development and tech transfer for manufacturing of various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. The Senior Scientist, DP Tech Transfer will play a critical role in leading technology transfer, process development and associated manufacturing of clinical and commercial cell and gene therapy drug products.
- Monitor and drive the tech transfer and execution of drug product development and cGMP manufacturing plans for gene and cell therapy customers.
- Develop robust manufacturing process and scale up procedures for engineering and GMP DP batches by applying QBD approaches as per Health Authority requirements.
- Identify and implement potential process improvements in conjunction with manufacturing team.
- Establish and support fill/finish capabilities to manufacture development, engineering and leading stability DP batches in pilot labs.
- Lead development of raw material testing strategies as appropriate
- Partner with Quality, Engineering and Manufacturing to ensure robust process tech transfer plans, detailed process flow diagrams, manufacturing batch records, and campaign summary reports.
- Author technical reports and regulatory filings. Present data to peers, functional management, clients, and health authorities.
- Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 3+ years’ experience, MS with 5+ years, BS with 7+ years.
- Thorough understanding of aseptic fill-finish unit operations; mixing and formulation, sterile filtration, filling, and lyophilization
- Experience in development, scale-up, technology transfer, and optimization of aseptic drug product manufacturing processes.
- Proven hands-on experience on equipment’s and manufacturing processes commonly used for allogeneic & autologous cell therapies and fill/finish of viral vectors.
- Demonstrated hands on experience with parenteral DP manufacturing including technical transfers and process validation deliverables.
- Experience with authoring regulatory documents for IND/IMPDs and BLAs.
- Strong communication skills and emotional intelligence to communicate and interact internally and with customers to drive program deliverables.
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.