Manager Analytical Development and Quality Control
vor 15 Stunden
**_The Life Science Career Network_**
**Manager Analytical Development and Quality Control**
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.
We are currently looking for a **Manager Analytical Development and Quality Control** till end of the year (with high probability for extension) based in Basel, Switzerland.
Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance and Drug Product. AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.
**Main Responsibilities**:
- Manages a team of up to 3 direct reports.
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial).
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOP’s.
- Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
- Representation of AD/QC in technical project team and CMC team meetings
- Conduct of release, retest, stability studies, transfer and validation analyses.
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
- Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
- Write-up and review of analytical protocols and reports and establish specifications.
- Assurance of adequate maintenance and operation of analytical equipment according to GMP.
- Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
- Ensuring initial and continuing training of the personnel of AD/QC and adaptation according to business needs
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Leverages workload of respective project members to assure timelines and budget are met.
- Establishment of 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
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
**Qualifications and Experience**:
- **_Relevant working/residency permit or Swiss/EU-Citizenship required_**:
- 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry with demonstrated previous success in a managerial function.
- Broad knowledge in analytical chemistry;
- Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development.
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