Biopharma Process Transfer & Tech Services Specialist

Tandem Project Management Ltd.; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Tandem Project Management Ltd. in West Dublin is seeking a Drug Substance - Technical Services Specialist to provide processing expertise for Upstream and/or Downstream manufacturing.

You will support technology transfer, process validation and routine commercial manufacturing in collaboration with Process Development, DS, Operations, Engineering and Quality teams. The role requires hands-on experience with biopharma unit operations, cGMP compliance and preparation of CTD sections, along with

Qualifications

• 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation.
• Technical and operational knowledge of multiple unit operations in cell culture processing.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Experience in authoring CMC sections of regulatory submissions.

Responsibilities

• Provide process expertise in Upstream (cell culture) and/or Downstream (purification) manufacturing.
• Author and review process transfer documentation, gap assessments, technical protocols and reports.
• Identify requirements for laboratory studies to support process fit and liaise with Global Process Development and CMOs.
• Support the introduction of new raw materials and consumables with BOMs and testing outlines.
• Work with Quality, Supply Chain and Manufacturing to ensure material availability and release timelines.
• Identify and implement process improvements to yield and cycle time.
• Generate documentation protocols and lead plant-supporting studies on the manufacturing floor.
• Occasionally work outside normal hours during engineering/validation batches and on-call.
• Provide on-floor troubleshooting and lead investigations into deviations and resolutions.
• Lead key process changes using change control systems.
• Ensure compliance with site EHS, cGMP and regulatory expectations and participate in audits.

Skills

Technical services

Process development

Manufacturing support

Regulatory knowledge

Education

B.Sc. in Biochemistry/Biology/Chemistry or B.Eng. Process/Chemical Engineering

M.Sc. or postgraduate in Biochemistry/Biology/Chemistry or Engineering

Job description

Tandem Project Management Ltd. in West Dublin is seeking a Drug Substance - Technical Services Specialist to provide processing expertise for Upstream and/or Downstream manufacturing.

You will support technology transfer, process validation and routine commercial manufacturing in collaboration with Process Development, DS, Operations, Engineering and Quality teams. The role requires hands-on experience with biopharma unit operations, cGMP compliance and preparation of CTD sections, along with