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 formulation, process development, tech transfer and support 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. Drug Product Manufacturing Science and Technology (DP MSAT) is a team within a Cell and Gene Therapies Drug Product Development in Center of Breakthrough Medicines. DP MSAT provides technical support for enabling readiness, robustness and GMP compliance of fill/finish manufacturing processes for gene and cell therapy products. Associate Director of DP MSAT ensures that formulation, fill/finish and cryopreservation steps in drug product manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Drug Product Process Development, Quality and Manufacturing teams
· Lead and coordinate drug product manufacturing effort between Process Development and Manufacturing organizations.
- Contribute to overarching Process Development goals by ensuring the effective integration of process knowledge into manufacturing operations.
- Work closely with Manufacturing team to ensure that drug product operations are thoroughly supported by high quality process documentation (batch records, forms, SOPs), controlled processes and verified technology.
- Responsible for change control ownership, investigations, and other quality system deliverables.
- Support fill/finish manufacturing processes from early clinical phase through and commercial manufacturing.
- Design and ensure DP process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
- Collaborate with Cell & Gene Therapy Drug Product Development and Quality organizations to establish and maintain the control of the process.
- Accountable for DP process FMEA original drafting and revision through drug product life cycle.
- Leverage DP MSAT team’s technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
- Provide on-the floor support during engineering and GMP DP manufacturing runs. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring
- Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and fill/finish of viral vectors.
- Robust experience in technology transfer from development into a cGMP Manufacturing.
- Direct experience of working in quality systems, authoring and review of GMP and technical documents.
- Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
- Thorough understanding of GMP requirements and their relation to process operations.
- Demonstrated project management capabilities.
- Self-motivated with strong interpersonal and organizational skills.
- Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.
Education & Experience
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 7+ years’ experience, MS with 9+ years, BS with 13+ years