Scientist/Engineer, Process Development Tech Transfer
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Scientist/Engineer, Process Development Tech Transfer

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

This role is responsible for a Scientist/Engineer who will support the process development technology transfer activities for viral vector and cell therapy manufacturing. This position will work closely with process development and manufacturing partners to transfer process/scale up to pilot-scale and/or transfer for GMP manufacturing.

Responsibilities

  • Work closely with process development scientist and/or client in process knowledge transfer to scale-up process for pilot scale
  • Support Process Fit to Plant evaluation
  • Author protocols to support pilot-scale manufacturing campaign
  • Provide planning and logistics support for pilot scale execution
  • Provide hands-on and technical support during execution of pilot-scale execution
  • Author knowledge transfer documentation for GMP manufacture (e.g., bill of materials, process flow diagrams, and sample plans)
  • Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
  • Provide scientific/engineering support for technology transfer and manufacturing of viral vectors and/or cell therapies

Qualifications

  • M.S. in Biological Sciences or Engineering with 1 year experience or a B.S. in Biological Sciences of Engineering with 3 years experience
  • Knowledge and/or experience in viral vector production, purification, or cell therapy is preferred
  • Detail oriented with strong written and verbal communication skills (e.g., clear and concise) and a team player
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Takes ownership of the assigned project, consulting with management and peers

Compensation: TBD

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