Analytical Development QC Manager

​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:

• Lead Analytical Development and Quality Control for late-stage CMC programs.

• Manage external analytical testing labs and supervise third-party labs.

• Develop and implement analytical methods for various determinations.

• Represent AD/QC in technical project and CMC team meetings.

• Oversee release, retest, stability studies, and validation analyses.

• Ensure proper documentation and review of analytical data.

• Support budget planning and monitor program spending.

• Establish source documents for regulatory submissions and interact with Health Authorities.

• Lead external lab work for troubleshooting and investigations.

Candidate Requirements:

• Degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering with relevant industry experience.

• Strong background in analytical chemistry and GMP/regulatory knowledge.

• Experience in medical devices is beneficial but not essential

• Experience in working with CMOs is advantageous

• Proficient in English with a life-long learning mindset and strong sense of accountability.

• Broad knowledge in analytical chemistry and basic knowledge in synthetic chemistry and drug development.

For further details, please contact Mark Bux-Ryan

analytical, QC, quality, control, GMP, manufacturing, method, development, validation, drug, product, development, regulatory, CMO, contract, freelance, interim, chemistry, synthetic, formulation