Lab Manager HPLC / Finished Product Analytics (m/f/x)

Direct message the job poster from SciPro

Driving SciPro's strategic client development and commercial strategy across the DACH region for permanent and contract staffing projects

The holder of this position will have organizational and technical leadership of the HPLC and Finished Product Analytics laboratory including workflow optimization. You will develop and validate analytical methods, review, approve and update regulatory compliant documentation and be responsible for change control / CAPAs. You will be training and developing employees of the HPLC and FPA teams, therefore very good knowledge of HPLC/FPA will be required!

What will your tasks as “Lab Manager HPLC / Finished Product Analytics (m/f/x)” be?

• Organizational and technical leadership of the GC/HPLC and Finished Product Analytics departments, including workflow optimization
• Development and validation of analytical methods
• Review, approval, and updating of regulatory-compliant documentation (specifications, SOPs, test instructions, and test protocols) and ensuring compliance
• Periodic reporting and responsibility for deviation and OOS (Out of Specification) reports
• Responsible for change control (CC and CAPA procedures)
• Further development of laboratory equipment and oversight of DQ, IQ, OQ, PQ execution
• Monitoring the requalification of equipment as well as the maintenance, qualification, and calibration of rooms and facilities
• Preparation, qualification, and procurement of reference standards
• Execution of stability studies
• Training and development of employees

Your requirements as a “Lab Manager HPLC / Finished Product Analytics (m/f/x)”?

• Successfully completed scientific degree or equivalent qualification with several years of experience in HPLC
• Experience in a GMP-regulated environment and knowledge of the EU-GMP guidelines, AMG, and AMWHV
• Experience in pharmaceutical analysis and handling of pharmacopoeias (especially EP/DAB/USP)
• Knowledge of pharmaceutical validation according to ICH guidelines and experience in the development and validation of test methods
• Experience in preparing and updating test instructions, test protocols, as well as processing deviations and OOS results
• Experience with chromatography software (preferably OpenLab)
• Experience with LIMS and ERP systems, as well as analytical instrumentation and evaluation software
• Proficiency in MS Office (especially Excel, Word, Teams, Visio, and Project)
• Excellent German and good English skills (spoken and written)
• Strong proficiency in chemical calculations
• Initiative, independent and structured working style
• High sense of responsibility and quality awareness
• Team player with resilience and flexibility
• This position reports directly to the Head of Quality Control
• Team consists of 19 people divided into 2 teams

Anticipated start date: asap – June/July 2025 is realistic

Information about our client:

Our client is a pioneering, medium-sized, third-generation family business. With a team of over 200 employees at two locations, they work on solutions for therapeutic approaches with a spirit of research and entrepreneurial creativity.

Sebastian Gotzler (Head of Commercial Strategy DACH)

Email: s.gotzler@sciproglobal.de

Tel: +49 89 262058887

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance and Research
• Pharmaceutical Manufacturing