Director, CMC Analytical Development

Skip to main content Director, CMC Analytical Development Pheon Therapeutics Cambridge, MA Apply Director, CMC Analytical Development Pheon Therapeutics Cambridge, MA 3 days ago 49 applicants See who Pheon Therapeutics has hired for this role Apply Save Report this job The Director of Analytical Development will lead and build analytical strategies to support the development, characterization, and lifecycle management of ADCs in the Pheon pipeline. The role requires deep technical expertise with a strong emphasis on analytical development of monoclonal antibodies, linker-payloads, and Antibody-Drug Conjugates (ADCs). This role is responsible for establishing robust analytical platforms, ensuring regulatory-ready data packages, and partnering cross-functionally to advance programs from early development through commercialization. The successful candidate will provide scientific leadership, manage internal and external (CDMO) resources, and serve as a key technical authority for CMC-related analytical activities.Responsibilities:Strategic & Scientific LeadershipDevelop and execute analytical development strategies to support ADC programs across all stages (IND-enabling through BLA).Serve as a subject-matter expert in ADC characterization and stability for phase-appropriate development of the pipeline.Define control strategies and analytical comparability approaches for process changes and lifecycle management.ADC ExpertiseLead analytical method development and qualification for:Monoclonal antibodiesADC conjugation metrics (DAR, drug distribution, free drug)Linker stability and payload characterizationOversee advanced analytical techniques such as:LC-MS / HRMS (intact, subunit, peptide mapping)SEC-MALS, CE-SDS, icIEF, HICBioassays (binding, cell-based potency)Ensure fit-for-purpose methods aligned with regulatory expectations for ADCs.Regulatory & CMC SupportProvide analytical input to IND, CTA, BLA, and MAA submissions.Author, review, and approve analytical sections of regulatory filings.Support regulatory interactions and health authority questions related to analytical development.Team & Resource ManagementManage external CRO/CDMO analytical partnerships and vendor relationships.Establish external laboratory workflows, and best practices as needed.Cross-Functional CollaborationPartner closely within CMC, Quality, Regulatory Affairs, Pre-Clinical, and Clinical teams.Support tech transfer of analytical methods to Quality Control and manufacturing sites.Drive risk-based decision making and problem solving across programs.Required QualificationsEducationPhD in Analytical Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, or related field. (MS with significant industry experience may be considered)Experience10+ years of industry experience in analytical development for biologicsDirect, hands-on experience with ADCs (required)Experience supporting programs through IND and into clinical development (Phase-3 development and commercial experience a plus)Technical ExpertiseBiologics and ADC analytical characterizationMethod development, qualification, and validationStability studies and comparability assessmentsStrong knowledge of ICH guidelines (Q2, Q5, Q6) and regulatory expectations for biologics/ADCsProven ability to lead multidisciplinary teams and external partnersStrong written and verbal communication skillsComfortable presenting to senior leadership and interacting...