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 Principal Scientist, Late Phase DP development will play a critical role in leading commercialization, process characterization and BLA-enabling studies for cell and gene therapy drug products.
- Shape and drive late phase strategy and execution of drug product studies in support of Phase III IND and BLA filing.
- Develop robust comparability, leading and in-use stability, container closure qualification protocols; lead the team executing the studies and report to the clients.
- Identify and implement potential process improvements in conjunction with cell therapy and viral vector teams.
- Establish and support process characterization studies for various modalities.
- Lead BLA-enabling activities and coordinate their execution either internally or outsourced, including formulation robustness, in-use stability and human factor studies.
- In collaboration with DP MSAT lead define the process validation strategy and oversee the execution to ensure robust commercial application package.
- Partner with Quality, Regulatory and Technical Program Leadership to deliver end-to-end strategy for commercialization of advanced therapies, including forecasting resources, building timelines and identifying work packages for quality modules.
- 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 commercialization.
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 7+ years’ of industry experience, MS with 9+ years, BS with 11+ years.
- Thorough understanding of formulation development, biophysical characterization, and stabilization principles.
- Familiarity with clinical preparation and administration procedures
- Thorough understanding of aseptic fill-finish unit operations; mixing and formulation, sterile filtration, filling, and lyophilization
- Experience in formulation development, in-use stability and compatibility studies.
- 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.