Senior Scientist, Analytical Development and Quality Control Expert
vor 2 Monaten
Debiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases. Our mission is to develop innovative therapies to improve patient outcomes and quality of life.
Job SummaryWe are seeking a Senior Scientist, Analytical Development and Quality Control to join our Pharmaceutical Development organization based at our Headquarters in Lausanne. The successful candidate will be responsible for defining the analytical development strategy and leading the analytical development activities on drug substances and drug products.
Key Responsibilities- Develop and implement control strategies for drug substances and drug products, ensuring compliance with regulatory requirements.
- Lead the development and validation of analytical methods, including chromatography, spectroscopy, and spectrometry techniques.
- Collaborate with cross-functional teams to develop and implement CMC strategies.
- Manage and challenge external partners, including CDMOs and CROs, to ensure conformity with scientific and documentary requirements.
- Contribute to the development of the CMC plan and provide key expertise to speed time to clinic.
- Master's degree or PhD in analytical chemistry, pharmaceutical sciences, or a related field.
- Minimum 5-7 years of industrial experience in pharmaceutical manufacturing, with a strong background in analytical development and validation.
- Excellent knowledge of synthetic API chemistry and peptide characterization.
- Strong understanding of regulatory and quality requirements, including GMP, Pharmacopeias, ICH, and FDA guidance.
- Excellent communication and interpersonal skills, with the ability to work in a matrix-based team environment.
Debiopharm offers a dynamic and international environment with a long-term vision. We provide opportunities for cross-functional collaboration and exposure to advanced scientific developments in oncology and anti-bacterial industries. Our company values innovation, people, and entrepreneurship, and we are proud to be an Equal-Pay certified employer.
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