Process Engineer

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.