Associate Director/Director, Drug Substance, MSAT

Summary

Manufacturing Science and Technology (MSAT) is a department within a Process Development Division in Center of Breakthrough Medicines. MSAT provides technical support for enabling readiness, robustness and GMP compliance of manufacturing processes for gene and cell therapy products. Associate Director/Director of MSAT, Drug Substance ensures that cell culture, cell selection, purification, isolation and formulation/bulk fill steps in drug substance manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Process Development, Quality and Manufacturing teams.

Responsibilities

• Lead a team of Engineers and Scientists, who perform as drug substance manufacturing SMEs in support of Process Development and Manufacturing organizations.
• Contribute to overarching Process Development goals to ensure the effective integration of process knowledge into manufacturing operations.
• Work closely with Manufacturing team to ensure that drug substance operations are thoroughly supported by high quality process documentation (knowledge transfer, batch records, forms, SOPs), controlled processes and verified technology.
• Responsible for change control ownership/assessment, investigations, product quality impact assessments, and other quality system deliverables.
• Support viral vector and/or cell therapy manufacturing processes from early clinical phase through and commercial manufacturing.
• Design and ensure DS process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
• Collaborate with Cell & Gene Therapy Drug Substance Development and Quality organizations to establish and maintain the control of the process.
• Accountable for DS process FMEA authoring and revision through drug substance life cycle.
• Leverage 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 DS manufacturing batches. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.

Qualifications

• Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 10+ years’ experience, MS with 13+ years, BS with 16+ years
• Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and cell culture derived 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.