Sr. Mrg., Proc & Analytical Dev (rAAV Vectors) - United States, United Kingdom, Switzerland
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- Reporting into the Company’s Technical Operations department, this position’s main responsibility will be to oversee production and testing of recombinant AAV vector starting materials for the Company’s allogeneic CAR T cell therapy at an external Contract Development and Manufacturing Organization (CDMO).
- The position will interact closely with internal Research teams as well as the CDMO and other outside organizations
- Oversee external development and manufacturing projects for recombinant AAV vectors from initial tech transfer through cGMP production, testing, and release.
- Manage CDMO to develop processes for rAAV vector cGMP-compliant manufacturing.
- Support technology transfer to manufacturing by generating development reports, reviewing master batch records, and providing technical support.
- Manage timelines and deliverables for projects at CDMOs.
- Assist in the technical review of supporting documents, reports, and change controls, including CMC sections of regulatory filings.
- Perform other duties, as assigned.
- BS, MS or PhD in Chemistry, Chemical or Biochemical Engineering or related field with 5 or more years of relevant experience in process development, manufacturing operations, and project management or oversight of external contract service providers.
- 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 viral vectors (preferably AAV) to a GMP environment.
- Knowledge and experience of application Quality by Design to process and analytical development.
- 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.