CMC Analytical Development and Drug Product Senior Scientist
vor 2 Monaten
Debiopharm is a leading biopharmaceutical company dedicated to the development of innovative therapies for oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through the development of high-quality medicines.
Job SummaryWe are seeking a highly skilled Senior Scientist to join our Pharmaceutical Development and Quality Control team. As a Senior Scientist, you will be responsible for leading the development and implementation of analytical and drug product strategies, ensuring the quality and safety of our products.
Key Responsibilities- Develop and implement analytical and drug product development strategies, including Life Cycle Management.
- Define specifications and justification for drug product, lead analytical method development programs, and define stability study strategies.
- Lead formulation development programs, production, and release of drug products for late-stage clinical trials.
- Develop and maintain regulatory and control strategies for drug products, ensuring compliance with Quality by Design principles.
- Manage suppliers' platform and experts, selecting optimal suppliers for drug product development, manufacturing, and controls.
- Act as the main point of contact for analytical and drug product activities performed at CDMO's/CRO's, ensuring conformity with external partners.
- Master's degree or Ph.D. in pharmaceutical sciences or equivalent by experience.
- At least 5 years' experience in pharmaceutical industry working in hands-on analytical and drug product development roles on late-stage development.
- Proven track record in development of liquid and solid parenteral dosage forms at an industrial level, and/or oral dosage form.
- Extensive expertise in pharmaceutical quality control of drug product/drug substance (small molecule, peptide), physico-chemical tests (such as chromatographic methods), microbiological tests.
- Solid knowledge of regulatory framework for pharmaceutical drug development and quality guidelines (GMP, Pharmacopeias, ICH, EMA/FDA guidances).
- Experience in outsourcing and managing a network of suppliers is a plus.
- Scientific curiosity, detail-oriented, and capable of identifying and solving complex scientific problems.
- Strong team spirit and ability to collaborate in a matrix organization.
- Fluent in English and ideally a good knowledge in French.
- International, highly dynamic environment with a long-term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
- Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.
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