Biotechnology Engineer – GMP Clinical Production (m/f)

Genera Research Ltd., a Croatian biotech company and pioneer in bone regeneration, is expanding its expert team to support implementing the OSTEOforUNION and OSTEOproDENT projects. This groundbreaking initiative focuses on the clinical-grade production of rhBMP6, a recombinant human bone morphogenetic protein used as the active substance in our novel drug candidate, OSTEOGROW, designed to heal non-union bone fractures. We actively recruit highly motivated professionals across multiple disciplines as we scale up GMP manufacturing, regulatory operations, clinical trials, and commercial readiness. We seek individuals who are not only technically qualified but also deeply committed to innovation, compliance, and improving patients’ lives through cutting-edge science. Position Overview As a Biotechnology Engineer, you will be directly involved in the upstream and downstream GMP production of the rhBMP6 drug substance derived from CHO cell culture. Your focus will be on the clinical grade manufacturing process, ensuring consistency, sterility, and compliance with strict quality standards. You will work closely with a multidisciplinary team to ensure that every production batch supports our clinical development and regulatory goals. Key Responsibilities Upstream Process: - Cell line inoculation and expansion under aseptic conditions in an isolator with MyCap single-use systems - Operation and monitoring of Biostat RM bioreactors - Maintenance of sterility and cGMP compliance throughout inoculation, expansion, and harvest Downstream Process: - Execution of cell harvesting, centrifugation, and clarification - Protein purification using FPLC and HPLC chromatography techniques - Buffer exchange, concentration, and final formulation of rhBMP6 drug substance General Duties: - Batch documentation, logbooks, and deviation reports following cGMP - Equipment calibration, qualification, and preventive maintenance - Collaboration with QA and QC teams to ensure product release and regulatory readiness - Participation in internal audits and continuous process improvement

- Master’s degree or higher in Biotechnology Engineering, Bioprocess Engineering, or related field - Hands-on experience in upstream and downstream processing in a biopharmaceutical or biotech production environment - Strong knowledge of Good Manufacturing Practice (GMP) regulations and sterile production - Team-oriented mindset, attention to detail, and strong problem-solving abilities - Excellent documentation and communication skills in English Proficiency in: - CHO cell culture techniques (inoculation, expansion, harvesting) - Biostat RM bioreactors, MyCap closed systems, and single-use consumables - Working in sterile environments and isolators - Protein purification using FPLC/HPLC chromatography systems