This job is currently Archived,
Sr. Mrg., Proc & Analytical Dev (rAAV Vectors) Cambridge United States, London United Kingdom, Basel Switzerland,
Posted on : 24 May 2017
- 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.
Cambridge MALondon UKBasel Switzerland
Find a Job Find Candidates