Senior/Principal Scientist, Cell Therapy Process Development
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Senior/Principal Scientist, Cell Therapy 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 leadership, individually or in a team, for planning, executing, analyzing, reporting on, and presenting on experiments related to Cell Therapy Process Development and Intensification. This position serves as a Cell Therapy technical leader within Process Development, and partners with the client to understand, discuss, and deliver against defined objectives. This role authors, reviews, and approves technical protocols and reports, and procedures. The position will support regulatory filings including specifications, validation, comparability, trend analysis, risk assessment, and product quality attribute assessment. The ideal candidate should have a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaboration skills.

Responsibilities

  • Lead scientist, driving the execution of study plans, individually or through a team, to meet agreed upon deliverables
  • Senior level management of work, defining goals and objectives, enabling team/project success, time management, problem solving, and risk identification/escalation to meet objectives
  • Derives the design and implementation of cell therapy process development strategies
  • Capability to be hands-on in laboratory work in developing, executing, and optimizing of cell therapy unit operations
  • Serve as SME for technology transfers from development to pilot scale and ultimately into vector manufacturing
  • Works closely with clients and technical team on appropriate process and characterization studies to enable manufacturing
  • Authors, reviews, and approves development and process protocols, reports, and batch records
  • Collaborates with Analytical Development to meet testing needs
  • Leads product quality attribute assessment and scoring to identify critical quality attributes (CQA)

Qualifications

  • BS (8+ years experience), MS (6+), or PhD (2+) in Chemical Engineering, Biology, or similar life sciences degree with expertise in cell therapy technologies and demonstrated laboratory proficiency
  • Expertise with most cell therapy equipment and able to train junior staff
  • Ability to define procedures with attention to detail, and enable successful execution of experiments at the bench
  • Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Significant knowledge and experience with cell therapy manufacturing in the biotech industry
  • Experience with Design of Experiment (DOE) or flow cytometry
  • Expertise with cell therapy process intensification and characterization
  • Strong communication skills (e.g., clear and concise) and a team player
  • Strong time and project management skills
  • 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, team, and peers
  • Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management

Compensation: TBD

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