Director, CMC Strategy and Tech Transfer

Description du poste

Join CSL Vifor as the Director of CMC Strategy & Technology Transfer. This role offers a dynamic opportunity to shape CMC strategies and drive innovation in a collaborative environment. Tasks Lead end-to-end CMC strategy from development to commercialization. Oversee technology transfer activities and ensure compliance with regulations. Manage cross-functional teams and guide decision-making for CMC challenges. Skills Requires a PhD or MSc in relevant fields and 12-15 years of industry experience. Expertise in CMC development and lifecycle management. Strong leadership and stakeholder management skills. About the job Director, CMC Strategy & Technology Transfer The Director of CMC Strategy & Technology Transfer is responsible for defining and executing the Chemistry, Manufacturing, and Controls (CMC) strategy across development and commercialization. This role ensures seamless transition of processes from development to manufacturing, including internal sites and external partners (CDMOs), while aligning with global regulatory expectations. The position integrates strategic planning, technical leadership, and cross-functional execution to enable successful regulatory submissions and reliable product supply. Location: Zurich - Glattbrugg, Switzerland Main Responsibilities & Accountabilities CMC Strategy Leadership Define and drive end-to-end CMC strategy from early development through commercialization Align CMC plans with overall program strategy, clinical timelines, and commercial objectives Lead CMC contributions to regulatory submissions (e.g., IND, BLA, MAA) Act as a key advisor to senior leadership on CMC risks, timelines, and investment decisions Technology Transfer Oversight Provide executive oversight of technology transfer activities (process and analytical) across sites Ensure robust transfer strategies, including scale-up, validation, and comparability Oversee transfers to/from CDMOs and global manufacturing sites Ensure readiness of receiving units (facility, equipment, training, documentation) Process Development & Manufacturing Integration Ensure alignment between Process Development, MS&T, and Manufacturing Guide process characterization, control strategy, and lifecycle management Drive manufacturing readiness for clinical and commercial supply Regulatory & Compliance Leadership Ensure compliance with global regulatory expectations, including International Council for Harmonisation (ICH Q8, Q9, Q10, Q11) Oversee preparation and review of CMC sections for regulatory filings Act as CMC representative during health authority interactions and inspections CDMO & External Network Strategy Define external manufacturing and development strategy (make vs. buy) Select and oversee CDMOs for development, scale-up, and commercial manufacturing Establish governance models and ensure performance, quality, and cost control Risk Management & Decision Making Identify key CMC risks (technical, regulatory, supply) and implement mitigation strategies Lead cross-functional decision-making for complex CMC challenges Ensure continuity of supply and inspection readiness Leadership & Team Development Lead and develop a team of scientists/engineers (Tech Transfer, MS&T, or CMC leads) Foster a culture of technical excellence, accountability, and collaboration Influence cross-functional teams without direct authority Qualifications & Experience Requirements Education Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field MBA is a plus Experience 12–15+ years in biotech/pharma industry Strong experience in CMC strategy, technology transfer, and manufacturing Proven leadership in regulatory submissions and health authority interactions Extensive experience with CDMOs and global manufacturing networks Key Skills & Competencies Deep expertise in CMC development and lifecycle management Strong understanding of biologics and/or small molecule processes Expertise in GMP, validation, and regulatory requirements Strategic thinking with strong execution capability Excellent leadership and stakeholder management skills Strong business acumen and risk-based decision making About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The 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 .