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 (Apply online only) in all correspondence