Requirements: English
Company: CK Group
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.
- Proficient in English.
- 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:- Competitive salary.
- 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.
Apply: It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.