Head of Analytical Development & Quality Control

The Head of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral  Dose and parenteral Drug Product programs.  The incumbent will have deep experience in analytical activities required to support early-stage to late-stage drug substance as well as  oral solid dose and parenteral drug products. Additional experience in antibody/ADC manufacturing-focused analytical activities is desirable. This individual will be responsible for operating in a 100% outsourced environment to establish and will manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.

As a key member of the Technical Operations team, this leader will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, , Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.

 

Key Respons