Director, CMC Analytical Development

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 Leadership

• 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.

ADC Expertise

• Lead analytical method development and qualification for:
• Monoclonal antibodies
• Linker stability and payload characterization

Oversee advanced analytical techniques such as:

• SEC-MALS, CE-SDS, icIEF, HIC
• Bioassays (binding, cell-based potency)
• Ensure fit-for-purpose methods aligned with regulatory expectations for ADCs.

Regulatory & CMC Support

• 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.

Team & Resource Management

• Manage external CRO/CDMO analytical partnerships and vendor relationships.
• Establish external laboratory workflows, and best practices as needed.

Cross-Functional Collaboration

• 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.

Required Qualifications

Education

• PhD in Analytical Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, or related field. (MS with significant industry experience may be considered)
• Experience
• 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)

Technical Expertise

• 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 Qualifications

• Experience supporting late-stage or commercial ADC programs
• Prior experience in a startup or fast-paced biotech environment
• Familiarity with novel linker-payload technologies