Associate Principal Scientist – Regulatory CMC for ADC Synthetic Moieties

About the role

This Associate Principal Scientist position (equivalent to Associate Director) leads regulatory CMC strategy for synthetic moieties of antibody‑drug conjugates (ADCs) and other bioconjugates. Reporting to the Director/Executive Director, the role drives global regulatory submissions and lifecycle management.

Key responsibilities

• Serve as Regulatory CMC Lead for drug‑linker, payload, linker, peptide and other chemically synthesized moieties across ADC programs.
• Develop and execute phase‑appropriate global CMC strategies, assess regulatory requirements, and identify risks.
• Prepare IND/IMPD, BLA/MAA, post‑approval variations, meeting packages and agency responses.
• Manage change controls, filing strategies and ensure compliance with global CMC guidelines.
• Collaborate with cross‑functional teams to align dossier content, data requirements and regulatory milestones.

Required profile

• Minimum B.S. in Chemistry, Chemical Engineering, Biochemistry or related field (advanced degree preferred).
• At least 10 years of regulatory CMC experience, including 5 years with an advanced degree.
• Proven ability to critically review scientific data and communicate complex issues clearly.
• Strong leadership, project management and stakeholder negotiation skills.

Required skills

• Regulatory CMC for ADCs and bioconjugates
• Drug‑linker and payload development
• IND, BLA, MAA preparation and eCTD submission
• Analytical chemistry and process chemistry
• Global CMC guideline knowledge (FDA, EMA, ICH)

What we offer

• Base salary $142,400 – $224,100 per year, with annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation and sick leave.