Technical Services Upstream Lead

3 weeks ago


Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

This is what you will do:

The Technical Services Commercial Upstream Associate Director is primarily responsible for upstream mammalian cell culture process performance for all current and future products in commercial manufacturing at Alexion's facility in Blanchardstown, Dublin. This role involves supporting upstream commercial manufacturing campaigns, overseeing Continued Process Verification for commercial processes in the Dublin facility, and collaborating closely with various departments such as Operations, Engineering, Quality, and Regulatory to ensure successful process support. The ideal candidate should have demonstrated expertise in leading a technical services team, driving process improvements, conducting investigations, implementing Continued Process Verification (CPV), performing Risk Assessment using QRM tools, and developing strategies and subject matter expert (SME) capabilities.

You will be responsible for:

  • Providing leadership to a team of approximately 6-8 Technical Specialists supporting multiple commercial upstream unit operations.
  • Owning the delivery of process documentation, technical protocols, reports, validation documentation, and strategy documents.
  • Identifying requirements for laboratory studies, collaborating with Process Development/MSAT, managing raw materials and consumables lifecycle, ensuring successful commercial batch deliveries, and working closely with Quality, Supply Chain, and Manufacturing Operations.
  • Capturing and verifying batch data, owning the Upstream Continued Process Verification (CPV) program, reporting process data for product quality reviews, serving as an SME on Upstream unit operations during regulatory processes, using data analytics tools for process improvements, generating documentation protocols, providing technical input for technology transfer, overseeing Upstream Process Performance Qualification, providing troubleshooting support, leading investigations, managing process changes, ensuring compliance, and authoring/reviewing technical documents for regulatory submissions.

You will need to have:

  • Minimum 10+ years' experience in Technical Services in a biological bulk drug substance manufacturing organization.
  • Proven ability to lead and manage high-performing technical teams, expertise in multiple unit operations in upstream processing, comprehensive understanding of cGMP requirements, good interpersonal skills, ability to present technical approaches effectively, drive for results independently, experience in process validation/verification, statistical analysis, detail-oriented, and technical writing competency.

We would prefer for you to have:

  • B.Sc./M.Sc. in Biochemistry, Biology, Chemistry, or equivalent, or B.Eng. in Process or Chemical Engineering, experience in authoring CMC sections of regulatory submissions, technical experience in supporting commercial manufacturing, leading yield improvement projects, and executing process validation.

Date Posted

30-May-2024

Closing Date

19-Jun-2024

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