Senior Scientist, Regulatory Affairs CMC – Synthetic Moieties of ADCs

About the role

The Senior Scientist will lead Regulatory Chemistry, Manufacturing and Control (CMC) for synthetic moieties such as drug‑linkers in antibody‑drug conjugate (ADC) and bio‑conjugate programs. This role provides regulatory leadership across cross‑functional teams and ensures delivery of milestones from development through post‑approval.

Key responsibilities

• Develop and execute global CMC strategies for drug‑linkers, payloads, linkers, peptides and other chemically synthesized moieties.
• Manage preparation and submission of INDs, IMPDs, BLAs, MAAs and post‑approval variations, including agency meeting packages and responses.
• Integrate synthetic‑moiety regulatory strategy with targeting component, conjugation process and drug product dossiers.
• Oversee change controls, regulatory filing strategies and ensure compliance with global regulations.

Required profile

• Minimum B.S. in Chemistry, Chemical Engineering, Biochemistry or related field (advanced degree preferred).
• At least 5 years of experience in Regulatory CMC or pharmaceutical development of chemically synthesized modalities.
• Experience supporting CMC regulatory submissions, health‑authority interactions and working with external development or manufacturing partners.

Required skills

• Analytical Biochemistry
• Analytical Chemistry
• Antibody Drug Conjugates (ADC)
• Biochemistry
• Bioconjugation
• Chemistry
• Drug Development
• Drug Formulations
• Electronic Common Technical Document (eCTD)
• External Manufacturing
• Ligand Binding
• Pharmaceutics
• Process Chemistry
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Communications
• Regulatory Compliance
• Regulatory Documents

What we offer

• Annual bonus and long‑term incentive eligibility.
• Comprehensive benefits including medical, dental, vision, 401(k) and paid time off.
• Hybrid work arrangement.