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 testing and stability programs. • Ensure timely release and disposition support for clinical materials. • Manage investigations involving OOS, OOT, deviations, and laboratory events. Regulatory and Quality Support • Author and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs for assigned programs. • Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations. • Support establishment of specifications and analytical control strategies throughout the product lifecycle. • May participate in regulatory agency interactions and inspections. • Ensure compliance with cGMP, GLP, GCP, and data integrity requirements. • Partner closely with Quality Assurance to maintain inspection readiness. • Support aud