Overview
Supervisor QC Lab Physico Chemistry role at Incyte. The QC Lab Supervisor Physico Chemistry is responsible for the QC Physico-Chemistry operational activities related to Drug Substance (DS) and, in the future, Drug Product (DP), In-Process-Control (IPC) testing and release at Incyte QC Bioplant. This includes planning testing, defining the analyses to be carried out, planning sampling, and managing internal and 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.
Responsibilities
* 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 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 GMP, 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.
* Conduct 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 within the defined approved budget.
Qualifications
* Bachelor's degree in Physico-chemistry or 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, and Change Control is 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).
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
Industries
* Pharmaceutical Manufacturing
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