Manager Analytical Development and Quality Control - Basel, Schweiz - CTC Resourcing Solutions

CTC Resourcing Solutions

Geprüftes Unternehmen

Basel, Schweiz

vor 2 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

The Life Science Career Network
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 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.