CMC Operations Lead: Stability, Supply & Strategy

ModeX Therapeutics, Inc.; Weston (MA); Presencial; USD 135.000 - 150.000; Jornada completa

Descripción de la vacante

ModeX Therapeutics is seeking a Manager, Technical Operations to lead CMC operational activities across drug product, analytical testing, stability, packaging, and distribution for global clinical programs. This role emphasizes collaboration with internal and external partners to ensure supply readiness and regulatory alignment.

The ideal candidate will drive risk assessment, inventory planning, and continuous improvement, guiding cross-functional teams through development milestones while

Formación

• 5+ years (MS/PhD) or 10+ years (BS) of biopharmaceutical industry experience supporting clinical development programs.
• Demonstrated experience leading complex CMC operational activities in a regulated environment.
• Strong understanding of biologics development, clinical supply, stability, and analytical testing.

Responsabilidades

• Lead CMC operational activities supporting global clinical development programs across DP, analytical, stability, packaging/labeling, storage, logistics, and distribution.
• Plan and execute stability programs and shelf-life extension activities with data review and risk assessment.
• Develop and maintain DP inventory plans and supply strategies for uninterrupted global studies.
• Coordinate with CDMOs, CROs, and external partners to align timelines, deliverables, and quality expectations.
• Monitor performance, resolve issues, and support leadership reviews to drive operational excellence.
• Lead readiness activities for analytical testing, clinical supply production, and distribution.
• Drive continuous improvement in data management, processes, and documentation.

Conocimientos

Biopharmaceutical industry experience

Project management

Cross-functional collaboration

Analytical thinking

Communication skills

Educación

MS or PhD in Pharmaceutical Sciences or related

BS in a related field with 10+ years of industry experience

Descripción del empleo

ModeX Therapeutics is seeking a Manager, Technical Operations to lead CMC operational activities across drug product, analytical testing, stability, packaging, and distribution for global clinical programs. This role emphasizes collaboration with internal and external partners to ensure supply readiness and regulatory alignment.

The ideal candidate will drive risk assessment, inventory planning, and continuous improvement, guiding cross-functional teams through development milestones while