Senior Analytical Chemist for OSD Product Development

il y a 4 jours

Gidy, Centre-Val de Loire, France Gi Group Temps plein
About Gi Group Consulting

Gi Group Consulting is an international consulting group with a strong presence in the healthcare industry. With a turnover of €2.84 million and a growth rate of 25%, we specialize in placing talents within the pharmaceutical sector. Our mission is centered around human values, and we dedicate our expertise in Life Sciences to support our clients.

Job Description

We are seeking a highly skilled Senior Analytical Chemist to join our team in the Gidy and Saclay region, France. The successful candidate will work closely with a prestigious pharmaceutical group, supporting their commercial manufacturing of Oral Solid Dosage (OSD) products.

Main Responsibilities
  • Serve as the analytical point of contact for OSD manufacturing of APIs, reference standards, and finished products at Contract Manufacturing Organizations (CMOs)
  • Facilitate technology transfers of analytical methods between different manufacturing sites, both domestically and internationally
  • Work closely with internal colleagues and external CMOs to manage analytical method activities efficiently
  • Manage and review deviation events and OOS/OOT investigations at CMOs, collaborating with QA and project team members as needed
  • Design and manage stability programs, analyzing relevant stability data using industry-standard tools and providing guidance on shelf-life and expiry dating
  • Prepare technical documents, including transfer protocols, validation reports, and regulatory submissions, ensuring compliance with cGMP and regulatory requirements
Requirements
  • A Ph.D. in Analytical Chemistry or related field with 5 years of experience, or a Master's degree with 7 years of experience, or a Bachelor's degree with 10 years of experience in OSD product development
  • In-depth theoretical knowledge and extensive hands-on experience in HPLC/UHPLC, GC, MS, NMR, UV, ICP, dissolution, and other solid dosage form analytical techniques
  • Familiarity with regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP)
  • Strong analytical and problem-solving skills, with the ability to apply statistical methods to process optimization and control
  • Excellent communication skills, with the ability to collaborate effectively with cross-functional teams and external partners
About You

The ideal candidate has a proven track record of managing relationships with external CMOs, ensuring quality and compliance while driving performance. Proficiency in English and French is essential. This role offers a contract duration of at least 2 years, with domestic and international travel up to 25%. Position based in France with the possibility of teleworking in a hybrid mode.

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