Ph3Director, CMC Strategy Technology Transfer /h3 pThe 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. /p pLocation: Zurich - Glattbrugg, Switzerland /p h3Main Responsibilities Accountabilities /h3 h3CMC Strategy Leadership /h3 ul liDefine and drive end-to-end CMC strategy from early development through commercialization /li liAlign CMC plans with overall program strategy, clinical timelines, and commercial objectives /li liLead CMC contributions to regulatory submissions (e.g., IND, BLA, MAA) /li liAct as a key advisor to senior leadership on CMC risks, timelines, and investment decisions /li /ul h3Technology Transfer Oversight /h3 ul liProvide executive oversight of technology transfer activities (process and analytical) across sites /li liEnsure robust transfer strategies, including scale-up, validation, and comparability /li liOversee transfers to/from CDMOs and global manufacturing sites /li liEnsure readiness of receiving units (facility, equipment, training, documentation) /li /ul h3Process Development Manufacturing Integration /h3 ul liEnsure alignment between Process Development, MST, and Manufacturing /li liGuide process characterization, control strategy, and lifecycle management /li liDrive manufacturing readiness for clinical and commercial supply /li /ul h3Regulatory Compliance Leadership /h3 ul liEnsure compliance with global regulatory expectations, including ICH Q8, Q9, Q10, Q11 /li liOversee preparation and review of CMC sections for regulatory filings /li liAct as CMC representative during health authority interactions and inspections /li /ul h3CDMO External Network Strategy /h3 ul liDefine external manufacturing and development strategy (make vs. buy) /li liSelect and oversee CDMOs for development, scale-up, and commercial manufacturing /li liEstablish governance models and ensure performance, quality, and cost control /li /ul h3Risk Management Decision Making /h3 ul liIdentify key CMC risks (technical, regulatory, supply) and implement mitigation strategies /li liLead cross-functional decision-making for complex CMC challenges /li liEnsure continuity of supply and inspection readiness /li /ul h3Leadership Team Development /h3 ul liLead and develop a team of scientists/engineers (Tech Transfer, MST, or CMC leads) /li liFoster a culture of technical excellence, accountability, and collaboration /li liInfluence cross-functional teams without direct authority /li /ul h3Qualifications Experience Requirements /h3 h3Education /h3 ul liAdvanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field /li liMBA is a plus /li /ul h3Experience /h3 ul li12–15+ years in biotech/pharma industry /li liStrong experience in CMC strategy, technology transfer, and manufacturing /li liProven leadership in regulatory submissions and health authority interactions /li liExtensive experience with CDMOs and global manufacturing networks /li /ul h3Key Skills Competencies /h3 ul liDeep expertise in CMC development and lifecycle management /li liStrong understanding of biologics and/or small molecule processes /li liExpertise in GMP, validation, and regulatory requirements /li liStrategic thinking with strong execution capability /li liExcellent leadership and stakeholder management skills /li liStrong business acumen and risk-based decision making /li /ul h3About CSL Vifor /h3 pCSL 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. /p h3Our Benefits /h3 pFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL. /p h3You Belong at CSL /h3 pAt 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. /p h3Equal Opportunity Employer /h3 pCSL 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 /p /p #J-18808-Ljbffr