Senior QC Specialist, Bioassay Lab (d/f/dm)

About the role

Sandoz is building a new biopharmaceutical manufacturing site in Lendava, Slovenia, and is looking for a (Senior) QC Specialist for its Bioassay Laboratory. The lab performs bioassays to assess the biological activity of drug substances and products, using cell cultures, cell-based assays and immunological techniques such as ELISA. The role supports analytical method transfers, validations and lifecycle management in a GMP environment, and helps build the laboratory and its team.

Key responsibilities

• Perform and evaluate bioassays to assess the biological activity of drug substances and products
• Maintain cell lines, work with cell cultures and prepare biological materials for testing
• Support method transfers, validations, troubleshooting and continuous improvement in line with GMP
• Review, approve and interpret analytical results used for batch release and stability testing
• Lead or support investigations of deviations, OOS, OOT and other atypical results, including root cause analysis and CAPA
• Maintain laboratory documentation such as SOPs, work instructions, protocols, reports and validation documents
• Take part in internal and external inspections, audits and regulatory interactions
• Help implement laboratory equipment, systems and best practices, and support colleagues with analytical and operational issues

Required profile

• University degree (Master's level or equivalent) in Biology, Biochemistry, Biotechnology, Microbiology, Biomedical Laboratory Science or a related field
• Minimum 2 years of relevant GMP experience; 5 years for the Senior level
• Experience in the pharmaceutical, biopharmaceutical or another highly regulated industry
• Good command of English, written and spoken

Required skills

• Hands-on experience with cell culture, cell-based assays, ELISA or other immunological methods is highly desirable
• Experience with analytical method transfer, validation or optimisation is an advantage
• Strong analytical thinking, attention to detail and problem-solving skills

What we offer

• Permanent contract with a 6-month probation period, 40 hours per week
• Annual gross salary of EUR 45,120 to 67,680 depending on experience and skills
• Annual bonus (STI), vacation allowance and Christmas bonus
• OurShare: employees of Lek d.d. receive shares of Sandoz AG each year
• Voluntary additional pension scheme fully covered by the employer, collective life and accident insurance, and a hybrid work environment