Manager Analytical Development and Quality Control
Vor 6 Tagen
**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.
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Basel, Schweiz Roche VollzeitAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
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Basel, Basel-Stadt, Schweiz Roche VollzeitJOB DESCRIPTION At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases...
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Basel, Basel-Stadt, Schweiz Roche VollzeitAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
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Basel, Basel-Stadt, Schweiz Roche VollzeitAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
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Group Head in Analytical Development
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Basel, Basel-Stadt, Schweiz Roche VollzeitJOB DESCRIPTION At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases...
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Basel, Basel-Stadt, Schweiz Roche VollzeitJOB DESCRIPTION At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases...
