Summary
We are looking for an Engineer, to join our Tech Transfer team in GMS&T.
The successful candidate will work under the tech transfer lead to support process and analytical clinical and / or commercial transfers, support and implement lifecycle changes, and support the training and start-up of new facilities.
He / she will collaborate with SMEs, user groups, quality groups, and other stakeholders to support the lead to accomplish transfer and start-up goals including : support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting.
He / she will also participate in strategic discussions, anticipate bottlenecks and transfer risks, and address risks / issues proactively, while fostering an environment of teamwork.
Duties / Responsibilities :
- Support the Tech Transfer Lead and interface with process SMEs to develop transfer strategies
- With direction of the Tech transfer Lead, support the following activities :
- Interface with manufacturing site operations teams and process / analytical SMEs to learn and implement processes, procedures, and analytics
- Support facility start-up efforts through specification, review, and testing of equipment and electronic systems
- Coordinate project planning, timeline, communications, and risk management activities
- Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies
- Provide technical input and investigation support for deviations / OOS
- Assist in the management of changes, and in the implementation of process improvements
- Provide technical input in support of regulatory submissions
- Interact with other CMC teams including Operations, QA, Development, and Regulatory
- Foster strong inter-team relationships to achieve common project goals
QUALIFICATIONS
- Candidate must have previous Technical Transfer experience
- Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment
- Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
- Familiarity with literature on process development and cell therapy
- Ability to assess risk and develop contingency plans for process risks
- Excellent problem-solving skills, including issue resolution
- Detail oriented with excellent verbal and written communication skills
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
Education / Experience / Licenses / Certifications :
- B.S. with 12+ years, M.S. with 10+ years in industry with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology / Immunology discipline
- Experience in leading Technical Transfers
- Experience with cellular therapies is strongly preferred
- Experience in a regulated manufacturing environment
- Experience working in a self-driven, performance / results oriented, fast paced matrix environment.
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