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.
• 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 136 017 in all correspondence.