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