About the Role
We are seeking an experienced
Analytical Development / Quality Control Manager
to support late-stage pharmaceutical development programs. This role involves managing external analytical testing labs, overseeing method development and validation, and ensuring compliance with GMP and regulatory standards. The position is embedded in a cross-functional CMC team and contributes directly to regulatory submissions and product quality assurance.
Key Responsibilities
* Lead analytical development and quality control activities for assigned CMC programs (Phase 3 and commercial).
* Manage external testing labs (CMOs/CROs) to ensure timely and compliant delivery of clinical trial materials.
* Develop, optimize, and implement analytical methods (e.g., dissolution, purity, blend uniformity, water content).
* Compile and interpret stability data for regulatory filings and shelf-life justification.
* Represent AD/QC in technical project and CMC team meetings.
* Oversee release, retest, stability, transfer, and validation analyses.
* Ensure proper documentation and review of analytical data and protocols.
* Draft and review CoAs, specifications, SOPs, and other quality documents.
* Support regulatory submissions (IND, IMPD, NDA/MAA) and respond to agency queries.
* Lead troubleshooting and special investigations related to analytical tasks.
* Collaborate with Technical Project Leads to meet development timelines.
* Manage outsourcing of analytical activities and contribute to supplier selection.
* Participate in technology transfer between internal and external labs.
Qualifications
* Degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering.
* Minimum 12+ years (BS), 9+ years (MS), or 2+ years (PhD) in the pharmaceutical industry.
* Strong background in analytical chemistry and GMP/regulatory requirements.
* Experience with solid-state characterization (e.g., PSD, DSC, XRPD).
* Excellent communication, time management, and problem-solving skills.
* Ability to work independently and in cross-functional teams.
* Fluent in English; additional languages are a plus.
* Experience with regulatory interactions is an advantage.
Work Location:
Allschwil
Country:
Switzerland
Schedule:
Fulltime
Job Type:
12 month contract
*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.
**Please note that we can only consider EU/Schengen applications