Director, Analytical Development & Quality Control

Director, Analytical Development & Quality Control

Watertown, Massachusetts, United States

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 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.

Key Responsibilities

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 transfers, validation activities, and technical governance of external laboratories.
• Establish performance metrics and ensure delivery against development and manufacturing timelines.
• Evaluate and implement new analytical technologies and outsourced capabilities as needed.

Required Qualifications

Education

• Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.

Experience

• 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology…