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Biopharmaceutical Manufacturing SME professional with over 10 years of experience. Strong Project Manager with ability to manage multiple projects and teams. Provide manufacturing support to Cell Therapy Facility clinical manufacturing operations. This position will work closely with support functions including Process Development, Supply Chain, and Quality to ensure successful ramp up to manufacturing operations. The candidate will support the tech transfer initiatives towards clinical Pilot Plant operations.


  1. Participate in development of Quality Systems (Deviation, Change Management, CAPA, etc.) as manufacturing business owner.

  2. Collaborate with manufacturing partners (Process Development, Supply Chain, Engineering, Quality) to develop processes and systems that enable compliant, successful technology transfers, operation, and lifecycle management of cGMP clinical manufacturing processes.

  3. Create programs to lead investigations as function of quality management systems to support manufacturing.

  4. Facilitate risk management and scenario planning programs for internal manufacturing operations.

  5. Lead and participate in the design, development, and qualification of manufacturing execution systems, equipment, and systems.

  6. Lead projects within the manufacturing team in support of clinical operations readiness.

  7. Lead training, mentoring, general manufacturing readiness, and performance metrics programs for manufacturing.

  8. Support operations (Technical, Quality, Supply Chain, Manufacturing) activities associated with the planning, manufacture, and delivery of products.

  9. Drive timely decisions and facilitate active communication and information flow to senior management.

  10. Utilize strong working knowledge of cGMP processes along with knowledge of regulatory compliance requirements to support plant inspection-readiness.

  11. Lead project deliverables using project management principles in preparation for routine manufacturing.

  12. Author technical documents for regulatory agency submission in support of manufacturing processes.


  • Bachelor’s degree in a scientific discipline (i.e., Biology, Bioengineering, Chemical Engineering, etc.)

  • 10+ years of experience in the biotech/pharmaceutical industry.  Experience in biologics development including cell therapy development or manufacturing, required. (A combination of education and experience may be considered).

  • Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.

  • Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.

  • Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems, and regulatory requirements.

  • Demonstrated in-depth skills in contract negotiation, budgeting, and project management.

  • Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive decisions among individuals from a variety of cultures and disciplines.

  • Demonstrated track record of effective leadership and partnership.

  • Specific experience with ERP, MES, QMS, LIMS.

  • Previous leadership experience in manufacturing or operations environment.

  • Experience with computer and documentation systems.

  • Good decision making with strong judgment through collaboration and consideration of other’s point-of-view.

  • Ability to understand manufacturing process and equipment related engineering tools, such as process flow diagrams, and/or engineering specifications/ requirements.

  • Expert problem-solver that leads with data, seeks subject matter expertise and is considerate of other’s point-of-view.

  • Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.

  • Work is generally performed in an office, manufacturing plant or clinical environment (ISO 7 or 5).




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