Job Description Summary
The future is ours to shape. / Prihodnost je v naših rokah.
Job Description
At Sandoz, we are building a state-of-the-art biopharmaceutical manufacturing site in Lendava and are looking for talented professionals who want to help shape its future. As a (Senior) QC Specialist within the Bioassay Laboratory , you will play a key role in establishing laboratory capabilities, supporting analytical method transfers, and ensuring the quality of biological medicines.
The Bioassay Laboratory is responsible for performing bioassays used to assess the biological activity of drug substances and drug products. The role involves working with cell cultures, cell-based assays, immunological techniques such as ELISA, and supporting the transfer, validation and lifecycle management of analytical methods within a GMP environment.
This is more than a traditional laboratory role. We are looking for a subject matter expert who is motivated by the opportunity to help establish a new laboratory, shape processes, and contribute to building a high-performing team in a growing biopharmaceutical organisation.
Key Responsibilities
Perform and scientifically evaluate bioassay testing to assess the biological activity of drug substances and drug products.
Work with cell cultures, maintain cell lines, and prepare biological materials required for analytical testing.
Support analytical method transfers, validations, troubleshooting activities, and continuous method improvement in compliance with GMP requirements.
Review, approve and interpret analytical results used for batch release and stability testing.
Lead or support investigations related to deviations, OOS, OOT and other atypical results, including root cause analysis and CAPA implementation.
Prepare, review and maintain laboratory documentation, including SOPs, work instructions, protocols, reports and validation documents.
Participate in internal and external inspections, audits and regulatory interactions.
Contribute to the implementation of laboratory equipment, systems and best practices, ensuring operational readiness and compliance.
Provide technical guidance and day-to-day support to laboratory colleagues in resolving analytical and operational challenges.
Play an active role in the establishment and continuous improvement of the Bioassay Laboratory.
What You'll Bring to the Role
University degree (Master's level or equivalent) in Biology, Biochemistry, Biotechnology, Microbiology, Biomedical Laboratory Science or another relevant scientific discipline.
Minimum of 2 years of experience in a GMP environment; for the Senior level, at least 5 years of relevant experience.
Experience gained within the pharmaceutical, biopharmaceutical or another highly regulated industry.
Hands-on experience with cell culture techniques, cell-based assays, ELISA or other immunological methods is highly desirable.
Experience with analytical method transfer, validation or optimisation would be considered an advantage.
Sound understanding of GMP requirements and laboratory documentation practices.
Good command of English, both written and spoken.
Proficiency in working with laboratory and digital systems.
Strong analytical thinking, attention to detail and problem-solving skills.
High level of accountability, integrity and ability to work both independently and collaboratively.
Proactive mindset, learning agility and a passion for continuous improvement.
What we offer:
Job location: Lendava, Slovenia
Contract type: permanent contract with 6-month probation period
Expected weekly working hours: 40
Pay range* (annual gross salary): €45.120,00 - €67.680,00
Salary* at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay…