Quality Control; QC Analytical Scientist

The Analytical Scientist in Quality Control (QC) supports the analytical characterization of lead molecules and investigational medicinal products in clinical development. The candidate must possess a strong scientific background in Analytical Chemistry or equivalent and ideally have drug development experience, preferably within a CMC or QC setting. The candidate must have a clear record of scientific accomplishments and ability to interact across functions within a dynamic matrix organization.

• Perform and/or coordinate the QC analytical method transfer, qualification and/or validation activities to/at external partner(s) or Contract Research Organizations (CROs), including review of required GMP documentation, for Drug Products, APIs and Starting materials
• Provide QC support (hands-on) to the Analytical Development (AD) team in the development & implementation of analytical methods intended to be transferred and executed in a QC environment
• Coordinate QC analytical testing activities (e.g. release, stability, characterization) of Drug Products, APIs and Starting materials by partners or at Contract manufacturing Organizations (CMOs) and CROs
• Coordinate and/or perform in house QC analytical routine testing and data generation in support of AD activities and MSAT process development following internal protocols and approved procedures
• Prepare internal technical documentation and support the review of third party scientific and technical protocols and reports as well as QC documents (SOPs, WIs, procedures and guidelines), assisting with data compilation and analysis
• Support QA/RA and Manufacturing activities by contributing to the investigation of quality-related events (e.g. OOS/OOT/OOE/OOTarget, deviations, change controls; CAPAs, etc.), with data gathering and technical assessment
• Perform work according to internal quality system and AD&QC SOPs/WI/PID
• Ensure instrument’s maintenance and calibration, as well as general laboratory organization and planning, including ordering supplies

• Master, Engineer degree and /or PhD in analytical related discipline in Analytical Chemistry, Biochemistry, or a related discipline
• Minimum 3 years’ pharmaceutical/biotech experience in an analytical related field, preferably interacting within multi-disciplinary teams
• Excellent knowledge and hands-on expertise in a wide variety of physicochemical techniques (e.g. HPLC/UPLC, LC-MS, IR, etc.) and/or in vitro bioassays (e.g. ELISA, cell-based assays, etc.).
• Experience working within or in close contact with a QC environment
• Familiarity with Ph. Eur./USP monographs and chapters, and ICH/FDA guidelines
• Good capabilities in organizing lab work and data documentation, with rigorous attention to detail

• Good oral and written English language skills
• Flexible team player with problem-solving skills and autonomous
• Fluency in French and a third language
• Advanced communication skills, verbal and written

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Quality Control Lead