Director / Senior Director, Process and Analytical Development - 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.