Technology Transfer Lead Drug Substance ADC

Tech Transfer Lead – Drug Substance (ADC) (m/f/d)

Location: Bavaria - Open to candidates willing to move to Germany (Must be an existing EU resident)

On behalf of an international biopharmaceutical company, we are seeking an experienced Tech Transfer Lead Drug Substance (ADC) to lead technology transfer and site launch activities for investigational and commercial Antibody-Drug Conjugate (ADC) manufacturing.

This role holds end-to-end responsibility for Drug Substance technology transfer from development through routine commercial manufacturing across internal and external production sites and CDMOs.

Key Responsibilities

• Lead and coordinate Drug Substance technology transfers and site launches for ADC programs across internal and external manufacturing sites
• Act as Technical Transfer Lead with accountability for planning, execution, risk management, and transition to routine manufacturing
• Chair and lead Site Launch Teams and associated cross-functional sub-teams
• Serve as the primary technical interface between CMC, manufacturing sites, and CDMOs
• Review and approve technical documentation related to manufacturing, tech transfer, site-to-site transfers, and PPQ
• Support CDMO scouting, technical evaluation, and site selection from a Drug Substance perspective
• Ensure manufacturing plans are aligned with CMC strategy, timelines, and validation requirements
• Identify, assess, and escalate CMC and manufacturing risks , recommending mitigation actions and transition milestones
• Support commercial manufacturing by resolving technical issues in collaboration with Quality and Supply Chain
• Contribute to CAPAs, remediation activities, and inspection readiness
• Provide technical input to CMC sections of regulatory submissions (IND/IMPD, NDA/BLA) and responses to Health Authorities
• Enable data-driven decision making , including KPI tracking and collaboration on digitalisation initiatives
• Participate in CMC governance and working group meetings , ensuring clear communication to stakeholders

Candidate Profile

• PhD in Biochemistry, Chemistry, Pharmaceutics, Engineering , or related discipline, or MSc with equivalent industry experience
• Extensive experience in biopharmaceutical Drug Substance process development and manufacturing , ideally with ADCs
• Strong knowledge of CMC development, technology transfer, GMP, and regulatory requirements
• Proven experience leading global, cross-functional teams and complex tech transfer activities
• Strong stakeholder management skills with the ability to influence and resolve issues
• Structured, strategic, and delivery-focused working style
• Excellent written and verbal communication skills in English
• Comfortable operating in a global, matrix environment