Aktuelle Jobs im Zusammenhang mit Senior Analytical Transfer Expert-Biopharma Specialist - Lausanne, Waadt - Axepta SA
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Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm 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...
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Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is a biopharmaceutical company based in Switzerland, dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our main activities include drug development, manufacturing, and digital health investment. We aim to develop innovative therapies targeting high unmet medical needs, acting...
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Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is a biopharmaceutical company dedicated to improving patient outcomes and quality of life through innovative therapies targeting high unmet medical needs. Our company is committed to developing and manufacturing pharmaceutical products that meet the highest standards of quality and safety.As a CMC Analytical Development and Drug Product Senior...
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Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to the development of innovative therapies for oncology and infectious diseases. Our commitment is to improve patient outcomes and quality of life through cutting-edge research and development.Job DescriptionWe are seeking a highly skilled Senior...
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Senior Analytical Transfer Expert-Biopharma Specialist
vor 2 Monaten
We are seeking a highly skilled Senior Analytical Transfer Expert to join our team at Axepta SA, a leading biopharma company. The successful candidate will be responsible for leading comprehensive validation studies to evaluate the performance of analytical methods, ensuring alignment with regulatory guidelines and Good Manufacturing Practices (GMP).
Key Responsibilities:
- Develop, review, and approve analytical transfer, validation, and verification protocols, data, reports, test methods, and related documentation.
- Interpret and analyze validation study results, preparing detailed and comprehensive reports.
- Serve as the analytical technical expert on multiple programs, collaborating with internal and external team members to advance projects.
- Provide expertise in analytical methods development for product development programs.
- Contribute to establishing a platform laboratory to ensure the rapid implementation of new methods in product development programs.
- Assist in budget definition and tracking, and identify resource needs for activities under your responsibility.
- Coordinate with external laboratories, if applicable, to ensure effective collaboration, cost management, and timeline adherence.
- Oversee the implementation of new raw materials by defining necessary tests in alignment with pharmacopeial standards.
- Act as a Subject Matter Expert (SME) and participate in internal/external audits and Health Authority (HA) inspections related to method validation/transfer.
- Conduct regulatory and technical monitoring to ensure compliance with evolving industry requirements.
Requirements:
- Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with minimum 5 -8 years of biotech industry experiences, in a GMP environment.
- Ideally between 8-10 years' experience in project management, analytical transfer and analytical validation.
- Strong understanding of Elisa, Virology, Microbiology, PCR.
- Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification.
- Fluent in French and English.
