Director Analytical Development and CMC

The Director, CMC Analytical Development will provide scientific leadership and technical expertise in analytical development for monoclonal antibodies, linker-payloads, and Antibody-Drug Conjugates (ADCs). This role is responsible for establishing robust analytical platforms, ensuring regulatory compliance, and collaborating cross-functionally to advance programs from early development through commercialization. The position involves managing both internal and external resources and serving as a key technical authority for CMC-related analytical activities.

Responsibilities:

• Develop and implement analytical strategies to support ADC programs from early development through regulatory submissions.
• Lead the development, qualification, and validation of analytical methods for monoclonal antibodies, ADC conjugation metrics, and linker-payload characterization.
• Oversee advanced analytical techniques such as LC-MS, SEC-MALS, CE-SDS, icIEF, HIC, and bioassays to ensure regulatory-ready data packages.
• Define and execute control strategies and comparability approaches for process changes and lifecycle management of ADCs.
• Provide analytical input and author sections for regulatory filings, supporting interactions with health authorities.
• Manage external partnerships with CROs and CDMOs, establishing workflows and best practices for analytical development.
• Collaborate with cross-functional teams in CMC, Quality, Regulatory Affairs, Pre-Clinical, and Clinical to support tech transfer and risk-based decision making.
• Serve as a subject-matter expert in ADC characterization and stability, providing scientific leadership and problem-solving across programs.

Qualifications:

• PhD in Analytical Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, or related field (MS with significant industry experience may be considered).
• 10+ years of industry experience in analytical development for biologics.
• Direct, hands-on experience with ADCs required.
• Experience supporting programs through IND and into clinical development; Phase-3 and commercial experience a plus.
• Expertise in biologics and ADC analytical characterization, method development, qualification, and validation.
• Experience with stability studies, comparability assessments, and knowledge of ICH guidelines (Q2, Q5, Q6).
• Proven ability to lead multidisciplinary teams and manage external partners.
• Strong written and verbal communication skills, with experience presenting to senior leadership and regulatory agencies.
• Experience supporting late-stage or commercial ADC programs preferred.
• Prior experience in a startup or fast-paced biotech environment preferred.
• Familiarity with novel linker-payload technologies preferred.

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