Analytical Development & Quality Control Director

Position Summary

The Director 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 Solid Dose (OSD) and parenteral Drug Product programs.  The incumbent will have deep experience in analytical activities required to support early-stage to late-stage 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 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, the Director will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.

Key Responsibilities

Analytical Development Leadership

• Lead, develop and execute phase-appropriate analytical method development and testing strategies and activities supporting Drug Product development, with an emphasis on small-molecule OSD and large-molecule parenteral Drug Product analytical method development and testing for assigned programs, including:

• Phase-appropriate small molecule oral solid dose drug product method development and testing (tablets, capsules, gelcaps)

• Phase-appropriate method development supporting antibody manufacture, ADC conjugation, and parenteral drug product manufacture.

• Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.

• Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.

• Depending on experience, incumbent may serve as the company's analytical subject matter expert for ADC development.

• Support characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.

• Guide implementation and interpretation of advanced analytical techniques such as:  HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, and bioassays.