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JMD Technologies Inc. · 12 hours ago

Associate Director, CMC (Stability)

United States

Contract

Remote

Lead/Staff, Director/Executive

10+ years exp

JMD Technologies Inc. is seeking an Associate Director, CMC (Stability) to lead drug substance and drug product stability programs. This role involves managing stability activities, coordinating with internal teams and stakeholders, and ensuring compliance with regulatory requirements.

Information Technology & Services

Hiring Manager

Rahul Srivastava

Responsibilities

Own and manage the drug substance and drug product stability program across development stages

Coordinate stability activities including set-downs, pulls, QC submissions, reporting, and study termination

Host routine and ad-hoc cross-functional meetings to communicate stability status and mitigate supply risks

Author, review, and approve stability sections of regulatory submissions

Manage stability sample inventory and lifecycle activities

Lead Analytical Development strategy discussions with cross-functional stakeholders

Author and manage drug substance and drug product specifications and justification documents

Initiate and manage expiry/retest date extensions

Generate, review, and approve applicable SOPs

Support selection and oversight of external analytical laboratories

Support Clinical Supply activities, including:

Review and approval of processes, batch records, and labeling

Investigation and disposition of temperature excursions

Investigation of quality incidents related to depots or clinical supply distribution

Qualification

Nucleic acid chemistryOligonucleotides experienceCMC/cGMP experienceAnalytical Development strategyRegulatory submissionsLeadershipCross-functional collaborationIndependent work