Director, Analytical Development & Quality Control

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 and antibody-drug conjugate (ADC) programs, with an emphasis on drug product, and antibody/ADC-focused analytical activities. 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 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.

Analytical Development Leadership

• Develop and execute phase-appropriate analytical strategies supporting small molecule and ADC development, with an emphasis on Drug Product and ADC method development for assigned programs.

• Lead analytical characterization efforts 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.

• 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.

• 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 audits of contract testing laboratories and manufacturing partners.

External Partner Management

• Manage relationships with contract laboratories and CDMOs.

• Oversee method