Summary
Manufacturing Science and Technology (MSAT) is a department within the Technology Development organization at the Center of Breakthrough Medicines. MSAT provides technical support for enabling readiness, robustness and GMP compliance of manufacturing processes for Cell and Gene 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 viral vector drug substance manufacturing SMEs in support of Process Development and Manufacturing organizations.
- Contribute to overarching Technology Development goals to ensure the effective integration of process knowledge, robustness, and right first time priciples into manufacturing operations.
- Work closely with Manufacturing Operations to ensure that drug substance manufacturing is 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 manufacturing processes from early clinical phase through and commercial manufacturing lifecycle.
- 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 CAPA.
- 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/or cell culture derived viral vectors.
- Demonstrated leadership of a team in a fast paced/dynamic environment.
- 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.
