Technology Transfer Specialist – Technical Services (BDS)

Tandem Project Management Ltd.; Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

Tandem Project Management Ltd. in West Dublin is seeking a Technology Transfer Specialist – Technical Services for a biopharmaceutical environment.

The role provides processing expertise to support technology transfer, process validation and routine manufacturing for Upstream and/or Downstream operations. You will author and review transfer documentation, gap assessments and reports, and work closely with Process Development, DS Process Sending unit, Operations, Quality and Regulatory to ensure

Qualifications

• Minimum 3+ years in Technical Services or Process Development in a biotech manufacturing environment.
• Experience authoring transfer documents, validation plans, and regulatory reports.
• Strong cross-functional collaboration with QA, Manufacturing, and Regulatory.

Responsibilities

• Provide process expertise for Upstream and Downstream manufacturing.
• Author and review transfer documentation, protocols, and reports.
• Coordinate studies with Global Process Development and CMOs.
• Support the introduction of new raw materials and consumables.
• Lead documentation and change control activities on the manufacturing floor.
• Support site audits and regulatory inspections.
• Ensure compliance with cGMP and EHS policies.

Skills

Technology transfer

Technical documentation

Cross-functional collaboration

cGMP knowledge

Education

BSc in Biochemistry/Biology/Chemistry or BEng Process/Chemical Engineering

MSc or postgraduate in Biochemistry/Biology/Chemistry or Eng

Job description

We’re looking for a candidate with direct, hands-on technology transfer experience who has owned or led assigned technical projects. Your CV should clearly identify the documents you personally authored or contributed to, such as transfer strategies, risk assessments and process plans, along with the types of validation protocols you authored, helped execute and wrote reports for. Experience limited to operations or supporting technology transfer activities will not be sufficient.

A Technology Transfer Specialist – Technical Services is required for a biopharmaceutical company in West Dublin. The successful candidate will provide processing expertise to support technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The ideal candidate will be responsible for providing support for the technology transfer of new/existing drug substance (DS) manufacturing processes to our clients' facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification

Responsibilities:

• Provide process expertise in one, or both of the following disciplines: Upstream (Cell culture focus) to include media preparation, large-scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification; Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
• Author and review process transfer documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents
• Identify requirements for laboratory studies to support process fit, decisions or process transfer, and liaise closely with Global Process Development and CMO’s to oversee the design and execution of studies
• Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
• Work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure the availability and release of materials to meet technology transfer and routine manufacturing timelines
• Identify and implement process improvements, e.g. yield, cycle time reduction
• Generate documentation protocols and lead the execution of plant-supporting studies and technical studies on the manufacturing floor at a commercial scale
• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
• Provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
• Lead any key process changes using change control system
• Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations
• Author and review common technical document (CTD) sections and reports for regulatory agency submissions
• Serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.

Qualifications & Experience:

• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• Minimum 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 Technology Transfer activities is advantageous
• Knowledge or experience of start-ups or systems would be ideal.
• Experience in authoring CMC sections of regulatory submissions.