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

This role is responsible for working closely with cell therapy process development team. This role reports to the Director of Cell Therapy Process Development and will work in close collaboration with the Technology Transfer, MSAT, Analytical Development, Drug Product, and Manufacturing teams to support departmental goals and objectives. This role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaborative skills.

Responsibilities

• Plan, execute, analyze, report, and present data related to cell therapy process development studies.
• Perform full or scale-down experiments to support process development and characterization of cell therapy manufacturing processes.
• Independently manage assignments including sourcing of materials, equipment uses, time delegation, and risk identification/escalation to meet objectives.
• Support technology transfer activities to ensure the successful and timely execution of manufacturing goals.
• Communicate department goals, expectations, and capabilities to internal team members, and external vendors or clients.
• Flexible for occasional weekend work.
• Other duties, as necessary.

Education & Experience

• B.S (5+), or MS in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic/autologous cell therapy technologies and demonstrated laboratory proficiency.
• Prior knowledge and experience in the development of cell derived therapies (iPSC, MSC, NK, or T-cell) is required.
• Knowledge and experience with most equipment and unit operations of cell therapy process development is required.
• Prior experience in the technology transfer of new technologies is highly preferred.
• Must be able to author and review process development study protocols, reports, and batch records as needed.
• Prior experience in process characterization, in-process testing, and sample handling is preferred.
• Ability to thrive in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
• Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management