Job Description

Summary We are seeking a motivated analytical expert for biopharmaceutical production within the framework QC testing for in-process controls, raw materials and drug substance. The role involves leading current and future analytical control strategies, focusing on release testing, method validation, and method transfer for new biopharmaceutical entities.

Major accountabilities:

• Coordinate, review and release of quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements
• Maintain excellent planning and collaboration with project team members (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders and colleagues)
• Participate in or create, review, approve registration documents
• Manage analytical weak points of assigned pipeline
• Perform deviations/OOX investigation
• Support troubleshooting for testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis, Bioburden and Endotoxin
• Lead validation and transfer activities for analytical procedures
• Lead qualification, maintenance, and calibration of instruments
• Lead LabOpex Projects

Key performance indicators:

• Timely completion of key deliverables
• Prompt reporting of missed deadlines and aim for shortest possible lead times
• Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities continuous readiness for inspection
• Proactively identify and implement cost-reducing optimizations

Minimum Requirements:

• MSc or PhD in biotechnology, analytical chemistry or related field, +3 years industry experience
• Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage
• Reliability, flexibility, resilience, and strong teamwork skills

Skills:

• Continuous learning
• Dealing with ambiguity
• Decision making
• GMP
• Industry standards
• Laboratory equipment
• Laboratory excellence
• Quality Control (QC) testing
• Quality Control sampling
• Self awareness
• Technological expertise

Languages :

• Fluent in English and German (spoken and written)

Skills Desired Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management