Pheon Therapeutics · 4 days ago
Director, CMC Analytical Development
Cambridge, MA
Full-time
Onsite
Director/Executive
10+ years expPheon Therapeutics is seeking a Director of Analytical Development to lead and build analytical strategies for ADCs in their pipeline. This role involves establishing robust analytical platforms and ensuring regulatory-ready data packages while providing scientific leadership and managing resources.
BiotechnologyLife ScienceMedicalTherapeutics
Responsibilities
Develop 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
Lead analytical method development and qualification for: Monoclonal antibodies, ADC conjugation metrics (DAR, drug distribution, free drug), Linker stability and payload characterization
Oversee advanced analytical techniques such as: LC-MS / HRMS (intact, subunit, peptide mapping), SEC-MALS, CE-SDS, icIEF, HIC, Bioassays (binding, cell-based potency)
Ensure fit-for-purpose methods aligned with regulatory expectations for ADCs
Provide 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
Manage external CRO/CDMO analytical partnerships and vendor relationships
Establish external laboratory workflows, and best practices as needed
Partner 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
Qualification
Required
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 development and commercial experience a plus)
Biologics and ADC analytical characterization
Method development, qualification, and validation
Stability studies and comparability assessments
Strong knowledge of ICH guidelines (Q2, Q5, Q6) and regulatory expectations for biologics/ADCs
Proven ability to lead multidisciplinary teams and external partners
Strong written and verbal communication skills
Comfortable presenting to senior leadership and interacting with regulatory agencies
Preferred
Experience supporting late-stage or commercial ADC programs
Prior experience in a startup or fast-paced biotech environment
Familiarity with novel linker-payload technologies
Company
Pheon Therapeutics
Pheon Therapeutics is an Antibody-Drug Conjugate (ADC) specialist that creates ADCs for a variety of difficult-to-treat cancers.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$188MKey Investors
TCG CrossoverResearch Corporation Technologies
2024-05-21Series B· $120M
2022-09-28Series A· $68M
2022-01-01Seed
Leadership Team
Cyrus Mozayeni
President & CEO
Arvin Yang
Chief Medical Officer
Recent News
Google Patent
2025-04-02
Company data provided by crunchbase