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
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Benefits
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Additional Information
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
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