Availability awaiting confirmation
We are waiting for a fresh update from the source. This page preserves the last received job details; current availability is not confirmed.
Job description
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
#J-18808-Ljbffr
Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.