Job Summary (Primary function)
The QC Lab Supervisor Physico Chemistry is responsible for the QC Physico-Chemistry operational activities related to Drug Substance (DS) and to a larger extent in the future, Drug Product (DP), In-Process-Control (IPC) testing & release at Incyte QC Bioplant.
This includes (but is not limited to) the planification of testing, the definition of the analyses to be carried out, the management of sampling (plan and execute), the management of internal & external results/data review and their approval within the defined lead time.
The QC Lab Supervisor is the point of contact for Quality Assurance, Manufacturing, Supply Chain, Warehouse, other Quality Control teams and External Laboratories.
The QC Lab Supervisor owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.
Essential Functions of the Job (Key responsibilities)
Leadership & Management
- Supervise, mentor, and develop QC analysts in the physico-chemistry laboratory.
- Plan and allocate daily laboratory activities to meet testing schedules and manufacturing timelines.
Laboratory Operations
- Accountable for the routine and non-routine QC Physico-Chemistry testing of in-process samples, drug substances with a variety of physico-chemical methods (e.g., HPLC, UPLC, CE, SoloVPE, ELISA.).
- Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and all relevant regulatory standards (FDA, EMA, ICH).
- Ensures that all QC equipment are appropriately qualified and fit for purpose for cGMPs activities
- Troubleshoots analytical instruments, assays, and technical issues to maintain laboratory efficiency.
Quality & Compliance
- Review and approve laboratory data, test results, and associated documentation.
- Conducts investigations of out-of-specification (OOS), deviations, and non-conformances.
- Maintain up-to-date SOPs, protocols, and training records to ensure regulatory compliance.
- Participate in audits and inspections
Continuous Improvement & Projects
- Drive laboratory process improvements, automation, and digitalization initiatives.
- Participate in method validation, transfer, and lifecycle management projects.
- Collaborate with cross-functional teams (Manufacturing, QA, Regulatory Affairs, Development) to support product lifecycle and inspections.
- Provide inputs for establishing the QC laboratory budget and operating in the defined approved budget
Qualifications (Minimal acceptable level of education, work experience, and competence)
- Bachelor (in Physico-chemistry, Biotechnology) with 10 years or higher degree (in Physico-chemistry, Biotechnology) with at least 10 years of experience in a laboratory environment.
- Strong experience in a GMP environment, in a biotechnology or pharmaceutical company.
- QC Laboratory supervision experience required demonstrated ability to set vision and direction for a team including setting expectations and motivating results Experience with Quality systems such as Deviation, CAPA, Change Control systems required
- Deep knowledge of Analytical testing and Pharmacopoeias
- Ability to work in a highly regulated and fast-changing environment
- Highly developed team spirit
- Proactivity and pragmatism
- Rigorous and organized
- Be able to make proposals
- Have a spirit of synthesis
- Language: French (fluent) and English (advanced; C1)
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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