Tech Transfer Specialist - Upstream/Downstream Biopharma

Tandem Project Management Ltd.

Dublin

Hybrid

EUR 70,000 - 100,000

Full time

7 days ago
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Job summary

Tandem Project Management Ltd. is seeking a Technical Services Specialist to support technology transfer, process validation, and routine commercial manufacturing for Upstream and Downstream operations in West Dublin.

The role requires collaboration across Process Development, DS, Operations, Engineering, Quality, Regulatory, and other departments to ensure successful start-up and qualification. The ideal candidate will have strong knowledge of cGMP, experience in biotech manufacturing, and a

Qualifications

  • Experience with cGMP in biopharma manufacturing.
  • Ability to author and review technical documents and reports.
  • Experience in technology transfer activities is advantageous.

Responsibilities

  • Provide processing expertise for Upstream and Downstream operations.
  • Prepare and review tech transfer docs, gap analyses, and validation plans.
  • Coordinate with Global Process Development and CMOs on study design and execution.
  • Support raw materials qualification, BOMs, and material specs.
  • Collaborate with Quality, Supply Chain, and Manufacturing to meet timelines.
  • Identify opportunities to improve yield and cycle time.
  • Lead process changes using change control systems.
  • Support audits and regulatory inspections.

Skills

Technical writing
CMC knowledge
Regulatory submissions

Education

BSc or equivalent in Biochemistry/Biology/Chemistry; or BEng in Process/Chemical Engineering
M.Sc. or higher in Biochemistry/Biology/Chemistry or related field

Job description

Tandem Project Management Ltd. is seeking a Technical Services Specialist to support technology transfer, process validation, and routine commercial manufacturing for Upstream and Downstream operations in West Dublin.

The role requires collaboration across Process Development, DS, Operations, Engineering, Quality, Regulatory, and other departments to ensure successful start-up and qualification. The ideal candidate will have strong knowledge of cGMP, experience in biotech manufacturing, and a

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