Associate Director of CMC, Drug Product

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Join us in shaping the future of multispecific antibodies and in vivo CAR‑T therapeutics. As a key member of our team, you will play a key role in technology transfer, scale‑up, and manufacturing initiatives that directly advance our platform. This position offers a blend of hands‑on experimental work and oversight of CDMO‑executed studies and requires deep expertise in chemistry, antibody conjugation, and LNP drug product process development in a regulated environment.

• Lead external drug product process development and manufacturing activities for multispecific antibody and LNP‑based programs.
• Oversee in‑house and CDMO LNP preclinical material production, contributing hands‑on to material preparation and analytical characterization to ensure quality and consistency.
• Manage CDMO‑executed process development studies, ensuring high‑quality, on‑time delivery.
• Drive seamless technology transfer from ModeX to external partners and CDMOs.
• Troubleshoot technical issues and implement process improvements across unit operations.
• Support strategic planning for platform advancement and technology readiness.
• Author and review technical protocols, batch records, reports, and regulatory documentation.
• Ensure adherence to regulatory and quality standards across development and manufacturing activities.

• Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or related discipline
  • Ph.D. with 5+ years of relevant industry experience
  • M.S./B.S. with 7–10 years of relevant industry experience
• Proven leadership in drug product process development for biologics, including oversight of CDMO activities.
• Strong technical expertise in antibody conjugation chemistry, lipid nanoparticle (LNP) formulation, and analytical characterization of complex biologics.
• Demonstrated experience executing technology transfer, scale‑up, and manufacturing in a regulated environment (GMP/GxP).
• Ability to work hands‑on in the lab and guide teams through experimental design, troubleshooting, and process optimization.
• Excellent communication and documentation skills, with the ability to author and review protocols, reports, and regulatory submissions.
• Cross‑functional collaboration skills, enabling effective interaction with R&D, CMC, Quality, and external partners.
• Strong project leadership, including planning, prioritization, and delivery of results in fast‑paced settings.

• Experience developing multispecific antibodies, ADCs, conjugates, or other complex biologics.
• Hands‑on experience with microfluidics‑based LNP formulation, lipid selection, novel formulation development and optimization, lyophilization.
• Hands‑on experience with downstream purification process development and unit operations including filtration, chromatographic separations, etc.
• Prior success leading process development and manufacturing activities at CDMOs from early research through IND‑enabling stages.
• Familiarity with regulatory expectations for novel modalities (e.g., LNPs, gene‑modifying therapies, in vivo CAR‑T).
• Experience supporting IND, IMPD, or BLA‑enabling CMC documentation.
• Track record of implementing process improvements, scaling strategies, or platform approaches for biologics or nanoparticle systems.
• Supervisory experience or team leadership in a development or CMC environment.
• Experience with design of experiments (DoE), statistical data analysis, and digital tools for process development.

ModeX Therapeutics is an Equal Opportunity Employer.