Head of Laboratory – GMP Clinical Production (m/f)

Genera Research Ltd., a Croatian biotech company and pioneer in bone regeneration, is expanding its expert team to support the implementation of 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 the Head of Laboratory, you will oversee the entire production workflow for rhBMP6, including upstream and downstream operations. You will manage laboratory staff, coordinate batch production, ensure regulatory compliance, and continuously optimize the production process. This leadership role requires deep technical knowledge, GMP experience, and team management capabilities. Key Responsibilities Production Oversight: - Supervise and coordinate upstream processes (CHO cell inoculation, expansion, harvesting) - Oversee downstream purification (FPLC/HPLC, filtration, concentration, formulation) - Lead sterile operations within isolators using Biostat RM bioreactors, MyCap systems, and single-use technologies GR-JO-Head of Laboratory.docx 3 Team Leadership & Management: - Lead, train, and supervise lab personnel to ensure high performance and compliance - Develop and enforce SOPs, workflows, and production schedules - Coordinate cross-functionally with QA/QC, Regulatory, and Project Management teams GMP & Regulatory Compliance: - Ensure compliance with EU GMP standards for clinical-grade biologics - Manage batch records, deviations, CAPAs, and change controls - Support audits and regulatory inspections; maintain facility inspection readiness Process Optimization & Technology Transfer: - Identify and implement process improvements to enhance efficiency and yield - Contribute to tech transfer activities for clinical and future commercial scale-up - Support CMC documentation and regulatory filings related to rhBMP6 production

- Master’s degree or higher in Biotechnology, Bioprocess Engineering, Molecular Biology, or a related field - Minimum 5 years of hands-on experience in GMP biologics manufacturing, ideally with recombinant proteins - At least 2 years in a supervisory or managerial role - Strong leadership, communication, and problem-solving skills - Fluency in English; Croatian language is a plus - Deep understanding of GMP regulations and sterile production standards Proficiency in: - CHO cell culture, sterile inoculation, closed system processing - Biostat RM bioreactors, MyCap systems, single-use technologies - Downstream purification with FPLC/HPLC chromatography