Manager Analytical Development and Quality Control
QLS are recruiting for a Manager Analytical Development and Quality Control to join a Biopharmaceutical Company based in Allschwil (Basel-Land) on a contract basis.
The company is specialized in the research and development of pharmaceutical, biological, and diagnostic products. It offers drugs for the treatment of insomnia, Fabry disease, cerebral vasospasm, resistant hypertension and lupus. The candidate will join the Analytical Development / Quality Control (AD/QC) – Drug product department. His/Her roles will have to ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.
The ADQC manager’s main responsibilities:
- Manage a team of up to 3direct reports and up to 4 projects
- Organize laboratory activities
- Development, experimentation, implementation, redaction and documentation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-, and potentially genotoxic impurity determinations
- Conduct of release, retest, stability studies, transfer and validation analyses
- Drafting and review of COAs and/or Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.• Training of Laboratory personnel on advanced tasks and GMP regulations
- Designing and performing laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision
Candidate’s Requirements:
- Degree in a chemistry, biology, biochemistry, pharmacy, or chemical engineering field as well as sufficient work experience in a relevant field
- Ability to plan, execute and document analytical experiments in a GMP-compliant pharmaceutical environment
- Good knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation
- Good knowledge in synthetic chemistry, drug substance or product processing and/or development
- Strong analytical thinking and problem-solving ability
- Ability to work independently and within a team, prioritize and deliver assigned tasks according to agreed timelines and budget
Apply: Please could you send any correspondence in English. For more information contact Kajenthi Chelliah at KChelliah@ckqls.ch or 0041 (0) 800 106106. Please quote reference 54224 in all correspondence.