Quality Control Manager
Analytical Development - Quality Control Manager, Allschwil
The position will be a temporary contract with the end client. The duration is yet to be determined.
Job Responsibilities:
The Manager working in AD/QC will have the following responsibilities and tasks:
- Responsible for Analytical Development and Quality control for assigned CMC program in late-stage development (typically phase 3 and commercial).
- Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .
- Point of contact and supervision for analytical 3rd parties’ labs, e.g., CMOs and CROs, for defined analytical tasks.
- Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations
- Representation of AD/QC in technical project team and CMC team meetings.
- 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.
- Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management.
- Establishment of source documents for IND, IMPD, and NDA/MA submissions
- Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
- College, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry.
- In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.
- Personality and disposition to manage professionals effectively in a matrix system.
- Willingness to limited travel.
- Proficient in English.
- Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
- Strong skills in timeline development and management.
- Broad knowledge in analytical chemistry.
It is essential that applicants hold entitlement to work in Switzerland.
