Sr. Mrg., Proc & Analytical Dev (CAR T Cell Therapies) - United States, United Kingdom, Switzerland
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- Reporting to the Vice President Process Development & Manufacturing this position’s main responsibility will be to develop and scale-up manufacturing processes for allogeneic CAR-T cell therapy projects. The position will interact closely with internal Research teams as well as external contract development and manufacturing organizations and also help to formulate the company’s manufacturing and supply strategy.
- Establish (together with senior management) and lead process development and manufacturing strategy for allogeneic gene editing-based products
- Develop cell separation, purification, gene editing, formulation, and related processes for cGMP-compliant manufacturing.
- Develop viral vector manufacturing, purification, formulation, and related processes for cGMP-compliant manufacturing.
- Optimize unit operations.
- Support technology transfer to manufacturing by generating development reports, reviewing master batch records, and providing technical support.
- Manage timelines and deliverables for technology transfer to CMOs.
- Oversee development of analytical methods for the evaluation of cells utilizing appropriate methods.
- Assist in the technical review of supporting documents, reports, and change controls, including CMC sections of regulatory filings.
- Perform other duties, as assigned.
- MS or PhD in Chemistry, Chemical or Biochemical Engineering or related field with 10 or more years of relevant experience in process development and in manufacturing operations.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Extensive experience managing biologics process development, technology transfer, and GMP operations.
- Excellent verbal and written communication skills.
- Proven ability to work independently as well as to collaborate with peers and work effectively in team-oriented environment; highly organized.
- Experience developing and transferring allogeneic and/or CAR-T cell therapies to a GMP environment.
- Knowledge and experience of application Quality by Design to process and analytical development.
- Experience directing work at contract development and manufacturing organizations.
- Building a Successful Team – Building an effective group that contributes to the larger success of the organization through setting clear expectations, providing context and building commitment.
- Communication and Teamwork – Effectively expresses ideas in written, visual and oral context. The ability to work cooperatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
- Results Orientation / Productive Work Habits– Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome.
- Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Risk and Compliance Management – Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies.