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Director, process development

CSL Plasma
Inserat online seit: 14 Mai
Beschreibung

For our global Technical Operations Organization, we are currently looking for a Director, Process Development The Director of Process Development leads the design, development, and scale-up of bioprocesses for biologics manufacturing. This role provides strategic and technical leadership to ensure robust, scalable, and compliant upstream and downstream processes across the product lifecycle, from early development to commercial production. Key Responsibilities: Bioprocess Development Leadership Lead development of Albumin downstream (purification) processes​ Define process strategies to optimize yield, quality, and scalability​ Establish critical process parameters (CPPs) and critical quality attributes (CQAs) Scale-Up & Technology Transfer Oversee scale-up from lab to pilot and commercial manufacturing​ Lead technology transfer to manufacturing sites and external partners (CMOs/CDMOs)​ Ensure process consistency and robustness across scales and sites Scientific & Technical Strategy Provide expertise in biologics production systems (e.g., CHO, microbial systems, viral vectors)​ Drive innovation and adoption of new bioprocessing technologies​ Lead troubleshooting and resolution of complex process challenges Regulatory & Compliance Ensure compliance with GMP and global regulatory expectations​ Support regulatory submissions (IND, BLA/MAA) with process development data​ Act as SME during inspections and audits Cross-Functional Collaboration Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams​ Align process strategies with product and portfolio goals Leadership & Organizational Development Lead and mentor multidisciplinary teams (scientists, engineers) ​ Manage budgets, resources, and project priorities ​ Build a high-performing, innovative team culture Lifecycle Management & Continuous Improvement Support process validation and continued process verification (CPV)​ Drive process optimization using data analytics and statistical tools (DOE, multivariate analysis)​ Implement improvements post-commercialization Your experience PhD (preferred) or Master’s in Biotechnology, Biochemical/Chemical Engineering, or related field ​ 12–18 years of experience in bioprocess or biologics development ​ Strong expertise in downstream processing ​ Proven experience in scale-up, tech transfer, and commercial manufacturing support ​ Deep understanding of GMP and regulatory frameworks (FDA, EMA) ​ Demonstrated leadership and team management experience ​ Understanding plasma process development preferable Key Skills Deep technical expertise in bioprocessing​ Strategic leadership and decision-making​ Strong problem-solving and analytical skills​ Cross-functional collaboration and stakeholder management​ Innovation and continuous improvement mindset ​ Are you interested? We are looking forward to receiving your online application. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

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