Technical Services Specialist (Upstream/Downstream)

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

Summary:

A Technical Services Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide processing expertise to support the 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:

• 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 organization.
• 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.
• Technical writing competency.