Senior QC Scientist

Senior QC Scientist

Greater Manchester

SRG are recruiting for a Senior QC Scientist to join a highly successful CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials and to approval.

Due to continued growth and expansion of the business they are seeking to hire a Senior QC Scientist to join their team in Greater Manchester to lead hands on QC testing, ensure the GMP compliance of finished products and support ongoing development & continuous improvement of QC Systems, methods and regulatory readiness.

Key Responsibilities

• Perform analytical testing including:
• HPL / UHPLC (Assay, Related substances & Cleaning verification methods)
• Dissolution Testing inc. method transfers, validations and troubleshooting.
• Compendial techniques – FTIR, pH, content uniformity, water content etc.
• Ensure compliance with GMP and regulatory standards, supporting audit and inspection readiness
• Write and review:
• Analytical methods and validation documentation
• SOPs and laboratory quality documents
• Certificates of Analysis and technical reports
• Manage stability studies from initiation through to reporting, including third-party liaison
• Support onboarding and lifecycle management of QC instrumentation (IQ/OQ/PQ)
• Supervise and mentor junior scientists, including training and competency sign-off
• Contribute to continuous improvement initiatives, including lean QC processes
• Support QC planning, laboratory organisation, and resource allocation

Required

• A degree or comparable experience in Chemistry, Pharmaceutical Sciences, Biochemistry, or similar relevant field.
• Proven QC / analytical experience within a similar GMP environment.
• Skilled in the operation of HPLC / UHPLC, FTIR and similar techniques.
• Experience with method validation, transfer, and technical documentation
• Good understanding of regulatory frameworks (e.g. EU GMP, ICH guidelines)
• Exposure to stability studies and data trending would be advantageous
• Previous experience mentoring or supervising colleagues is desirable

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