Analytical Development - Quality Control Manager
We are seeking a highly skilled and experienced Analytical Development - Quality Control Manager, to join our team in Allschwil, Switzerland. The successful candidate will be responsible for managing Analytical Development and Quality Control, for assigned CMC programs in late-stage development, ensuring compliance with GMP and regulatory guidelines.
Responsibilities :
* Manage external analytical testing labs and third-party labs for defined analytical tasks.
* Develop, optimize, and implement analytical methods with external testing labs.
* Represent AD / QC in technical project team and CMC team meetings.
* Oversee release, retest, stability studies, transfer, and validation analyses conducted by analytical service providers.
* Proper documentation of all analytical activities according to Good Documentation Practices.
* Review, interpret, and document analytical data.
* Write-up and review of analytical protocols and reports.
* Independently review scientific work in project-related activities.
* Support budget planning and monitoring for the assigned program.
* Establish source documents for regulatory submissions and interact with Health Authorities.
* Lead external laboratory work to support troubleshooting, investigations, deviations, and other analytical tasks.
* Set and accomplish product development timelines.
* Summarize, defend, and communicate results and product quality issues to management.
* Manage the outsourcing of analytical activities to CROs / CMOs in a compliant way.
* Participate in technology transfer between laboratories.
Qualifications :
* College or university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering.
* 12+ years BS, 9+ years MS, or 2+ years PhD experience in the pharmaceutical industry.
* Strong background in analytical chemistry and knowledge of GMP / regulatory requirements.
* Effective management skills in a matrix system.
* Diligent attention to details and willingness to travel.
* Superior communication, time-management, and team-working skills.
* Ability to work independently, take initiative, and seek technical and scientific solutions.
* Strong problem-solving skills and ability to work with diverse teams.
Day-to-day :
The successful candidate will be responsible for managing Analytical Development and Quality Control for assigned CMC programs in late-stage development, ensuring compliance with GMP and regulatory guidelines. This will involve overseeing external analytical testing labs, developing and implementing analytical methods, representing AD / QC in technical project team and CMC team meetings, and managing the outsourcing of analytical activities to CROs / CMOs.
Benefits :
* Health and wellness benefits.
* Opportunities for professional development and growth.
* Dynamic and collaborative work environment.
* Opportunity to work on innovative pharmaceutical projects.
If you are a highly skilled and experienced professional, with a strong background in analytical chemistry and a passion for pharmaceutical development, we encourage you to apply for this exciting opportunity. Join our team and contribute to the advancement of pharmaceutical innovation.
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