Associate Scientist/Scientist Downstream Process Development
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Associate Scientist/Scientist Downstream 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.

Summary

This role is responsible for supporting process development for viral vector purification for client programs. The primary responsibility is the design, execution, and analysis of study results. Study results are summarized and presented to clients. The ideal candidate should have prior process development experience with common purification techniques such as clarification, chromatography, UF/DF and ultracentrifugation. Experience in viral vector purification is a plus but not a requirement since purification techniques from biologics are transferrable.

Responsibilities

  • Design, execution, and analysis of purification studies covering clarification, chromatography, UF/DF, and ultracentrifugation.
  • Execution of filter sizing studies such as Vmax and Pmax.
  • Design and analysis of studies using statistical software such as JMP.
  • Authors client-facing reports and presentations summarizing study results.
  • Presentation of protocols and study results to clients.
  • Supports process-scale up to the non-GMP pilot lab including authoring documents such as process descriptions and providing in-lab support during a pilot run.
  • Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing.
  • Collaborates with external vendors to evaluate new technologies for viral vector purification.
  • Supports day-to-day activities such as sample management and buffer preparation.

Qualifications

  • BS/MS/PhD with a life science or engineering background.
  • 1-5 years of experience with biologics and/or cell & gene therapy downstream process development.
  • Experience with common purification methods such as chromatography, filtration (depth filtration, UF/DF) and ultracentrifugation.
  • Experience with filter optimization methods such as Vmax and Pmax.
  • Experience with process scale-down or scale-up.
  • Experience with statistical software, e.g., JMP.
  • Experience with Design of Experiment (DOE).
  • Experience with late-stage process characterization.
  • Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Strong communication skills (e.g., clear, and concise) and a team player
  • Strong time and project management skills
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Takes ownership of the assigned project, consulting with management and peers
  • Able to understand and interpret data/information and its practical application

Compensation: TBD

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