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.
Key responsibilities
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
Qualifications & Skills
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
Personal characteristics should include:
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
Activity rate: 100%
Reports to: Quality Control Lead
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Key responsibilities
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
Qualifications & Skills
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
Personal characteristics should include:
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
Activity rate: 100%
Reports to: Quality Control Lead
#J-18808-Ljbffr
