Biopharma Technical Services & Process Transfer Specialist

Tandem Project Management Ltd.; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

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

You will work closely with Process Development, DS Process Sending, Operations, Engineering, and Quality teams to ensure smooth facility start-up and process qualification. The role requires 3+ years in biopharma Technical Services or manufacturing support, strong knowledge of

Qualifications

• 3+ years' experience in Technical Services/Process Development/Manufacturing Support in biopharmaceuticals.
• Knowledge of multiple unit operations in cell culture processing.
• Understanding of cGMP requirements for biopharmaceutical manufacturing.
• Experience in Technology Transfer activities is advantageous.
• Experience authoring CMC sections of regulatory submissions.

Responsibilities

• Provide processing expertise for Upstream and Downstream manufacturing.
• Author and review transfer documentation, protocols, and reports.
• Identify requirements for lab studies and manage studies with external groups.
• Support introduction of new materials and BOMs, specs, and testing needs.
• Collaborate with Quality, Supply Chain and Manufacturing to meet timelines.
• Lead process improvements to enhance yield and reduce cycle time.
• Generate protocols and lead studies on the manufacturing floor.
• Occasional out-of-hours engineering and validation batch support.
• Troubleshoot processing issues and lead investigations into deviations.
• Lead key process changes via change control; ensure regulatory compliance.

Skills

Technical writing

cGMP knowledge

Technology transfer

Process development

Biopharma manufacturing

Regulatory inspections support

Education

B.Sc./B.Eng. in Biochemistry/Biology/Chemistry or related

M.Sc. or postgraduate qualification in related field

Job description

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

You will work closely with Process Development, DS Process Sending, Operations, Engineering, and Quality teams to ensure smooth facility start-up and process qualification. The role requires 3+ years in biopharma Technical Services or manufacturing support, strong knowledge of