Senior Scientist/Manager, Process Development (Downstream)

King of Prussia

Summary

The Center for Breakthrough Medicines’ mission is to accelerate the delivery and affordability of lifesaving and life-changing advanced therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM 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 and Allogeneic Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

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.

This role is responsible for supporting process development for viral vector purification of client’s Cell and Gene therapy programs. The senior scientist/manager will lead a team of engineers and scientists in the design, execution, and analysis of client’s purification experiments. The role provides the opportunity to be a scientific lead for a client’s program with direct interaction with clients. The ideal candidate should have experience with development and scale-up of purification techniques such as filtration, e.g., depth filtration, chromatography, TFF and ultracentrifugation. Experience in viral vector purification is preferred but not a requirement.

Responsibilities

  • Serve as a scientific and technical leader for the Downstream Process Development team.
  • Contribute to the stand-up, optimization, and management of the Downstream organization, facilities, and programs.
  • Grow and develop a high-performing team of PhD & non-PhD staff to develop and understand processes for the purification of viral vectors.
  • Manage team of scientists within Downstream Process Development. Hires and develops employees within the department in support of Downstream 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 Downstream 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

  • 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.
  • Experience (dependent on education and expertise) in downstream process development and scale-up; cell and gene therapy experience preferred.
  • Experience with common purification techniques such as chromatography, filtration (depth filtration, UF/DF) and ultracentrifugation.
  • 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.
  • Entrepreneurial experience dealing with customers in product development.
  • 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.
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