qc chemist Sawston, England
Job description
Company Information
Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products. We currently manufacture in aseptic suites in London and at our newly licensed facility in Sawston, Cambridge.
Job Summary
The successful candidate will work within a fast-paced multidisciplinary Good Manufacturing Practice (GMP) QC environment, working closely with internal stakeholders to support product release, technology transfer and validation of new methodology.
Key responsibilities will include:
Performing and supporting analytical method validations and routine testing in compliance with cGMP requirements.
Leading complex quality events e.g., change controls, OOS, non-conformances.
Experience in routine activities, such as cell-based assays (cell culture, flow cytometry, immunoassays) and molecular assays (qPCR, ddPCR).
Performing self-inspection activities and contributing to health and regulatory authorities inspection readiness.
Supporting the critical operations by ensuring the laboratory and general equipment is maintained to GMP standard.
Performing periodic review of environmental monitoring data.
Reviewing analytical control charts and supporting complex data analysis.
Performing and documenting risk assessments / impact assessment / root cause analysis
Supervising laboratory activities within the team
The successful candidate will have the following experience/qualifications:
BSc. in a Science or related discipline.
Membership of an appropriate professional body (e.g., RSB).
Demonstrable experience working within a Pharmaceutical/Biotechnology microbiology function.
Knowledge of the MHRA requirements & Biostatistics.
Experience working within a GMP environment, with ATMPs and, biological products.
Experience of analytical method validation and technology transfer.
The is a fantastic opportunity to join the Quality team for a growing organisation. We offer an attractive base salary and benefits package.
