Director of Manufacturing, Science and Technology
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Director of Manufacturing, Science and Technology

King of Prussia, PA

The 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.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

Center for Breakthrough Medicines is seeking a highly motivated Director of Manufacturing Science and Technology (MSAT). Reporting to the Head of Tech Transfer, the Director of MSAT position plays a leading role in troubleshooting advanced therapy manufacturing processes and establishing process robustness and late-stage clinical manufacturing strategies. The Director of MSAT will lead a team of scientist/ engineers responsible for technical support for GMP manufacturing, investigations for process related issues and implementation of process changes to enable seamless transition from clinical to commercial operations. This position involves close collaboration within Tech Transfer Leads, Process Development, Manufacturing/Operations, Quality Assurance, Regulatory groups. This position requires strong technical expertise in advanced therapy (cell and/or gene therapy) manufacturing processes. 

Responsibilities

  • Establish and lead an MSAT team within Process Development at Center for Breakthrough Medicines
  • Serve as lead subject matter expert in advanced therapy manufacturing sciences
  • Provide technical review of clinical manufacturing batch records, SOPs, deviations, and investigations
  • Participate in regulatory and internal audits.
  • Design and oversee experiments in collaboration with Process Development, Analytical Development, and other teams to support investigations and process improvements for manufacturing
  • Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and robustness for cell and gene therapy manufacturing processes
  • Identify and implement process improvements for cell and gene therapies during early and late-stage clinical manufacturing and associated technical transfers
  • Collaborate with Process Development, Manufacturing, and Analytical Development on actions necessary in preparation for late-stage trials and filing of BLA
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements by providing technical analysis to support impact assessments and investigations
  • Build strong relationships with stakeholder groups to create a culture of high performance 

Qualifications

  • B.S./M.S./Ph.D. in Biochemistry, Chemical/Biomedical Engineering or Biology/Immunology discipline or equivalent • 12+ overall years’ experience with 5+(Ph.D) 10+(BS/MS) years relevant industry experience in of Late-stage Process Development or MSAT with management responsibility
  • Thoroughly understand the cell and gene therapy manufacturing processes along with associated equipment and technologies to support issue resolution for manufacturing operations
  • Strong understanding of global regulations, regulatory filings, and validation/qualification requirements
  • Familiar with cell therapy supply chains and manufacturing methods
  • Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements
  • Experience in effectively managing scientific groups and projects
  • Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment
  • Demonstrated skill in leading project teams tasked with resolving complex production related issues

Compensation: TBD

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