Director Analytical Development

We are partnering with an innovative and growing biotechnology company as they expand their CMC organization with the addition of a Director of Analytical Development. This is a newly created and highly visible role, offering the opportunity to build and lead analytical strategy for the company’s lead Antibody-Drug Conjugate (ADC) programs as they advance through clinical development.

This individual will serve as a key scientific and technical leader, responsible for defining and executing analytical development strategies, ensuring robust characterization, method development, and regulatory-ready analytical packages to support clinical and future commercial programs.

Key Responsibilities

• Lead and execute analytical development strategy for the company’s ADC and biologics programs across preclinical and clinical development stages.
• Provide scientific and technical leadership for all analytical activities, including method development, qualification, validation, and lifecycle management.
• Oversee analytical characterization of ADCs and antibody-based products, including identity, purity, potency, stability, and safety-related attributes.
• Ensure analytical methods and data packages are suitable for regulatory submissions (IND, IMPD, BLA/MAA), with direct involvement in preparing and reviewing CMC sections.
• Serve as the analytical subject matter expert for ADC-specific technologies, including linker-payload chemistry, conjugation processes, and product heterogeneity.
• Collaborate closely with Process Development, Formulation, Quality, Regulatory, and Clinical teams to support integrated CMC strategies.
• Stay current with emerging analytical technologies and industry best practices relevant to ADCs and complex biologics.
• Chromatographic methods (HPLC, UPLC, SEC, RP-HPLC, IEX)
• Mass spectrometry (intact mass, peptide mapping, DAR analysis)
• Capillary electrophoresis (CE-SDS, icIEF)
• Potency and binding assays (ELISA, cell-based bioassays)
• Stability and forced degradation studies
• Method qualification and validation per ICH guidelines
• Analytical comparability and characterization strategies for biologics and ADCs

Qualifications & Experience

• Degree in relevant field plus 8+ years of experience in analytical development within the biotech or pharmaceutical industry.
• Direct, hands‑on experience supporting Antibody‑Drug Conjugates (ADCs) and/or antibody-based biologics is essential.
• Strong background in analytical method development and characterization across multiple stages of drug development.
• Experience preparing and reviewing CMC sections for regulatory submissions (IND/IMPD/BLA/MAA).
• Demonstrated ability to act as a scientific and technical leader within cross‑functional teams (CMC, Regulatory, Clinical, Quality, Manufacturing).

Apply today to learn more or reach out directly with your CV to

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