Senior QC Specialist(m/w/x)

# Senior QC Specialist ( 1 Year Novartis Contract) **Basel (City)** | **Full time** **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. **Job Description** **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