Technical Services Specialist (Drug Substance)

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

Drug Substance - Technical Services Specialist (Upstream/Downstream)

Summary:

A Technical Services Specialist 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.