Director, Analytical Development & Quality Control

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. Collaborate with external CDMOs and internal process development teams to define CQAs and control strategies for ADC products. Quality Control Oversight Establish and lead QC strategies across clinical manufacturing operations for assigned programs. Oversee external GMP testing activities including raw materials, IPCs, release…