The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

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.

Main Responsibilities:

  • 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.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.

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