Head of Process Development

Job Description : HEAD OF PROCESS DEVELOPMENT SPAIN creative, organized and open-minded Senior Scientists to lead and direct the technical operations related to Upstream Process (USP) and Downstream Process (DSP) development for biopharmaceutical products (including recombinant proteins and mRNA-based therapies). If you are interested in developing your career as a Head of Process Development Senior Scientist in a pioneer and supercool CDMO start-up located in Barcelona,??don't doubt it and apply to it! This key leadership role will be responsible for driving innovative strategies, overseeing process development and process characterization activities, and ensuring the scalability and efficiency of bioprocesses in line with regulatory requirements. The successful candidate will collaborate closely with cross-functional teams, including Analytical Development, Quality, MSAT and Manufacturing, to deliver high-quality biopharma products. Strategic Leadership • Develop and implement the overall strategy for USP and DSP development in alignment with Leanbio's clients objectives • Lead, mentor, and develop a high-performing team of process scientists and engineers. • Ensure that process development and process characterization activities are aligned with industry best practices, regulatory guidelines (eg, FDA, EMA), and Leanbio's internal standards. Technical Oversight • Direct the design, optimization, and scale-up of upstream and downstream biopharmaceutical processes, including fermentation, cell culture, purification, and formulation. • Significant experience in chromatography techniques and bioreactor cell culture processes is essential. • Drive process innovation for recombinant protein and mRNA production, enhancing yield, purity, and efficiency. • Troubleshoot and solve complex technical challenges in USP and DSP, ensuring robust and scalable manufacturing processes. • Oversee technology transfer to GMP manufacturing, ensuring seamless and efficient transitions. • Lead the design, planning, execution, analysis of results, and closure of Process Characterization studies, ensuring data-driven decisions and strong scientific justification for process parameters. Collaboration & Communication • Collaborate closely with Analytical Development Department. Additionally when required with Quality Control, MSAT and Manufacturing to ensure successful product development and commercialization. • Provide technical expertise and leadership in regulatory submissions and audits. • Maintain strong relationships with external partners and CDMOs to ensure project timelines and technical requirements are met. Continuous Improvement • Drive continuous improvement initiatives in process development, including implementation of new technologies and automation strategies. • Ensure compliance with Leanbio's quality systems, process documentation, and regulatory requirements. • Monitor emerging trends in the field of bioprocessing and identify opportunities for process improvement and innovation • Minimum of 18+years of experience in biopharmaceutical process development, with a focus on USP and DSP for recombinant proteins and mRNA products. • Expertise in cell culture, fermentation, purification technologies, and downstream processing for biopharmaceutical products. • Familiarity with the latest advancements in bioprocessing technologies and methods, including automation and process intensification. • Strong expertise in the design, planning, organization, execution, analysis of results, and closure of Process Characterization studies. • Proven leadership ad decision-making experience in managing technical teams and cross-functional projects. • Excellent problem-solving abilities, with a focus on innovation and continuous improvement and ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously. • Extensive experience in process design, scale-up, and technology transfer for GMP manufacturing. • Solid knowledge of regulatory requirements (FDA, EMA) for biopharmaceutical manufacturing Education PhD or MSc in Biotechnology, Biochemistry, Biological Engineering, or related field.

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