Sr Scientist/Manager, Upstream Process Development
Apply Now

Sr Scientist/Manager, Upstream 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

The Senior Scientist/Manager role within Upstream Process Development is responsible for leading the strategy, development, and characterization of upstream manufacturing processes used to manufacture viral vectors for use in/as cell and gene therapy products. This individual will define and direct activities within their Upstream Process Development team to plan, execute, and document experiments for the development of fit-for-purpose manufacturing processes. The Senior Scientist/Manager will serve as a leader within the Upstream function and support management of process, analytical, and characterization knowledge related to the Center for Breakthrough Medicine asset pipeline.

Responsibilities of primary importance are to grow/manage (Manager level only) and lead a high performing team responsible for delivering work packages in partnership with clients to advance products from Research to Development, and on to GMP manufacturing. The successful candidate will take accountability to ensure all documentation and reports are accurate, complete, and suitable for use in support of production, characterization, and regulatory approvals.

The Senior Scientist/Manager will be responsible for developing the upstream portion of the processes, planning to avoid delays, and leading the activity to deliver a robust and effective product and manufacturing process.

Responsibilities

  • Serve as a scientific and technical leader for the upstream process and team.
  • Contribute to the stand-up, optimization, and management of the Upstream organization, facilities, and programs.
  • Grow and develop a high-performing team of PhD & non-PhD staff to develop and understand processes for the production of viral vectors.
  • Manage team of scientists within Upstream Process Development. Hires and develops employees within the department in support of Upstream objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions. (Manager level only)
  • Establish and incorporate sound scientific and technical principles as well as Good Documentation Practices.
  • Make decisions, based on the professional judgment, experience, and cGMP and clinical regulations/guidance.
  • Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit.
  • Evaluate the functional strengths and developmental areas in the Upstream Process Development team and drive a culture of continuous improvement.
  • Work with internal stakeholders in Process Development, Manufacturing, Supply Chain, Business Development, Analytical Development, & Program Management to successfully sign and deliver on client programs.
  • Understand and incorporate Quality by Design (QbD) for programs.

Qualifications

  • Experience (dependent on education and expertise) in upstream process development, including mammalian cell culture, viral vector production, and scale-up; cell and gene therapy experience preferred
  • Bachelors' degree in biochemistry, chemical engineering, bioengineering, or related technical field with 7 years of experience in biopharmaceutical development, Master’s degree with 5 years or PhD with 3 years.
  • People management (Manager level only) and organizational skills; ability to prioritize and manage through complex processes/projects.
  • Excellent organization, multitasking, and oral and written communication skills.
  • Solid foundation in the fundamentals of biochemical engineering and cell biology.
  • Entrepreneurial experience dealing with customers in product development.
  • Working knowledge of cGMPs related to the production of microbial therapeutics.
  • Experience with Cell Expansion technologies, single use platforms, cell banks, cell line development and optimization, viral stock generation, and suspension and adherent bioprocessing.
  • Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
  • Rational persuasion particularly in the discussions with customers.
  • Ability to define problems, establish facts, draw valid conclusions and make decisions.
  • Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
  • Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.

Compensation: TBD

Apply Now