Associate Director of Protein & ADC Drug Substance - Remote

About the Role

We are seeking an experienced Associate Director of Protein & ADC Drug Substance to join our team remotely. In this role, you will provide overarching drug substance support, primarily focusing on protein purification and ADC bioconjugation. You will serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors.

What You'll Do

• Provide on-site operational support at collaboration partners and CDMOs for Drug Substance process development and clinical GMP production.
• Engage directly with local collaboration partners, CDMOs, and vendors to support drug substance development.
• Review project documentation, including development reports, risk analysis, and qualification/validation reports.
• Translate technical documents for technical transfer and due diligence activities.
• Organize technical visits at collaboration partners or CDMOs for project-related visits and technical transfers.
• Support internal audits and Health Authority inspections as a subject matter expert.

Requirements

• Master’s degree in Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field.
• At least 5 years of relevant professional experience in an international and highly regulated environment.
• Proven experience in mAb and ADC Drug Substance process technologies.
• Sound knowledge of GMP and experience with regulatory filings for biologicals.
• Excellent project management skills and the ability to work in cross-functional CMC teams.
• Strong communication and negotiation skills, capable of conveying complex technical matters clearly.

Nice to Have

• Experience in CMC development of early- and late-stage projects.
• Familiarity with strategy definition and execution in drug development processes.
• Proficiency in additional languages is a plus.

What We Offer

• Competitive remuneration packages based on role, location, and qualifications.
• Comprehensive benefits to support the wellbeing of our team members.
• Opportunities for professional growth and development.
• Flexible work arrangements with a focus on remote work.
• Supportive company culture that values diversity and inclusion.