Analytical Development - Quality Control Manager
Location:Allschwil, Switzerland
Schedule:Full-time (100%)
Duration:12 months
About the Role:
Working with a global business that works on the synergy between both generic and branded medicine, we are now seeking an experienced Analytical Development - Quality Control Manager to ensure that the Drug Substance (DS) and Drug Product (DP) meet the highest quality standards during development.
Key Responsibilities:
1. Lead Analytical Development and Quality Control for late-stage CMC programs.
2. Manage external analytical testing labs and supervise third-party labs.
3. Develop and implement analytical methods for various determinations.
4. Represent AD/QC in technical project and CMC team meetings.
5. Oversee release, retest, stability studies, and validation analyses.
6. Ensure proper documentation and review of analytical data.
7. Support budget planning and monitor program spending.
8. Establish source documents for regulatory submissions and interact with Health Authorities.
9. Lead external lab work for troubleshooting and investigations.
Candidate Requirements:
10. Degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering with relevant industry experience.
11. Strong background in analytical chemistry and GMP/regulatory knowledge.
12. Experience in medical devices is beneficial but not essential
13. Experience in working with CMOs is advantageous
14. Proficient in English with a life-long learning mindset and strong sense of accountability.
15. Broad knowledge in analytical chemistry and basic knowledge in synthetic chemistry and drug development.
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