REQUIREMENTS:

• BSc/MSc (or equivalent) in a relevant life sciences field with biopharmaceutical or pharmaceutical experience.
• Experience with analysis of pharmaceutical/ biopharmaceutical products.
• Experience in regulatory and client audits for GMP compliance.
• Experienced people manager, with demonstrated competency in building effective teams and track record in effectively resourcing, scheduling to deliver client projects.
• Significant experience in leading the design and delivery of microbiology methods and associated method validation, transfer and cGMP release and stability testing within the biotechnology industry.
• Experience of quality systems within a GMP facility – CAPAs, Out of Specifications, Deviations, Change Control Requests.
• Understanding of CMC development for the manufacturing process stages of the drug substance.
• Experience of working in CDMO / CRO environment and leading client projects.
• Experience in writing technical specifications, method validations and test methods.

KNOWLEDGE & SKILLS

• Knowledge of pharmaceutical standards and regulations, GMP.
• Proven industry experience in analytical techniques including but not limited to organism classification, Environmental Monitoring, LAL testing, Identification – Gram Staining, Water testing, Bioburden testing
• Focus on continuous improvement with the ability to evaluate systems to improve system functionality and efficiency.
• Strong organisational skills with a track record of successfully managing laboratory operations

KEY ROLES AND RESPONSIBILITIES:

• Ensure cGMP readiness for manufacturing activities by ensuring appropriate procedures, specifications, facility monitoring, and equipment and methods are appropriately validated in line with quality procedures and guidelines.
• Supervise the development, optimization, qualification and/or technical transfer of methods and the validation/verification of compendial or developed assays for cGMP testing.
• Supervise and plan resources, to execute scientific studies and testing of facilities/utilities, raw materials, process development and GMP in process, product release and stability to ensure delivery on time, on budget and in compliance with the established quality standards.
• Write and review technical reports for issue to the client or inclusion to support internal Regulatory Submissions.
• Building an effective team through supervision of Senior Scientists and Scientists resolving day to day technical issues and championing continued professional development by setting objectives and giving performance feedback regularly throughout the year.
• Manage GMP regulated laboratory, driving compliance and continuously improving our microbiological processes.

We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully Integrated Gene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisation

• We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
• We offer state of the art working environment on site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes