CBM

Full Time EE - Onsite

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

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.