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

Center for Breakthrough Medicines is seeking a highly motivated Principal/Sr. Scientist, Tech Transfer Leads to provide leadership and guidance across the Cell Therapy Process Development team and to direct the tech transfer activities from Client to Process Development to Manufacturing and Client to Manufacturing. The ideal candidate should be experienced in advanced cell therapies technology transfer, cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities

• Serve as lead, subject matter expert in advanced cell therapy Product and Processes, at all stages of development including process development, tech transfer, technical operations, and regulatory filings
• Collaborate effectively with cross-functional teams including Process Development, Project Management, MSAT, Supply Chain and Manufacturing, as well as the Client to accomplish deliverables for technology transfer.
• Lead on robust process tech transfer plans, detailed process flow diagrams (PFD), bill of materials (BOM), manufacturing batch records, and campaign summary reports
• Identify and implement potential process improvements in conjunction with manufacturing and MSAT team.
• Serve as a scientific and technical lead for tech transfer related issues and investigations.
• Contribute to cell therapy process development laboratory activities

Qualifications

• Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 5+ years’ experience, MS with 7+ years, BS with 9+ years
• Demonstrated experience with tech transfer, process development, scale-up, pilot, GMP technical operations, and regulatory approvals (IND and BLA)
• Hands-on experience with most equipment and unit operations of cell therapy processes development
• Strong communication skills and emotional intelligence to communicate and interact internally and with customers to drive program deliverables
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient