Manager Analytical Development and Quality Control for Solid Formulations (5157) (5157)
The Life Science Career Network
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Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a:
Analytical Development and Quality Control Manager for Solid Formulations
for a contract of 12 months initially, based in Basel.
- Conducting release, retest, stability studies, transfer and validation analyses;
- Reviewing, interpreting and documenting analytical data including results from method development, release, retest, validation, stability, and transfers;
- Writing and reviewing analytical protocols and reports and establish specifications;
- Independently designing and executing projects or experiments with hands on involvement;
- Contacting 3rd parties, e.g., CMOs and CROs, for defined analytical tasks;
- Establishing source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings;
- Designing and leading laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently;
- Managing outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- University degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering;
- At least 5 years of experience in the pharmaceutical industry with demonstrated previous success in a managerial function;
- Experience in late phase solid formulations projects;
- Working experience with China and regulatory background;
- Knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required;
- Experience in the development and performance of analytical tests for a variety of drug substances and products.
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