Associate Scientist/Scientist Process Development
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Associate Scientist/Scientist Process Development

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.

Position Summary:

The Discovery Labs Process Development team is seeking a highly motivated Associate Scientist/Scientist who will support pipeline process development activities for viral vector manufacturing. As Process Development Scientist, you be a subject matter expert and support upstream development, downstream development, and process analytics under the supervision of senior scientists. This position will play a key role in helping execute experiments in a team environment as well as independently lead lab studies to develop upstream or downstream manufacturing processes.

Primary Responsibilities:

  • Execution process development activities from Design of experiment to execution of established protocols.
  • Performing experiments in the development, optimization and scale-up of production processes.
  • Preparing and reviewing process development protocols, data analysis summaries, technical reports, and other relevant process documentation.
  • Experiments will be performed to identify and define critical process parameters and critical attribute parameters.
  • Work design and scale-out vector processes, and support process characterization, as well as draft documentation for regulatory.
  • Define formulation targets and identify critical and controlled process parameters.
  • Lead process optimization studies as needed.
  •  Develop and update process protocols/SOP's and batch records.
  • Lab supply ordering and inventory as required.
  • Follow GXP practices and maintain a safe working environment.
  • CBM is a CDMO and candidates must interact with clients as needed.
  • Support experimental preparation.
  • Perform process analytics and report results.
  • Maintain detailed electronic records.

Education & Experience

  • B.S. in chemical engineering, chemistry, biochemistry, or biology/molecular biology or related area; M.S. degree preferred
  • 3 – 5 years of relevant scientific or technical experience in the life sciences industry or equivalent
  • A background in either Upstream Advance Therapeutic Technologies (Single Use Bioreactors, Cell Factories, Cell Culture Expansion) or Downstream Purification, Chromatography, TFF, Ultracentrifugation, UF/DF) would be beneficial.
  • Experience in cell culture including materials, instruments and technologies is essential
  • Experience with viral vector production is preferred
  • Familiarity with upstream and downstream biologics manufacturing, tissue culture, column chromatography and other purification processes
  • Effective communication skills (verbal, written, interpersonal)
  • Experience drafting protocols and technical reports
  • Hands-on experience with analytical techniques a plus
  • Must be able to interact with cross-functional teams
  • Analytical and problem-solving skills
  • Ability to work well under pressure and meet deadlines

Compensation: TBD

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