ModeX Therapeutics Inc · 1 month ago
Associate Director of CMC, Drug Product
Weston, MA
Full-time
Onsite
Lead/Staff
5+ years expModeX Therapeutics Inc is focused on advancing multispecific antibodies and in vivo CAR-T therapeutics. The Associate Director of CMC, Drug Product will lead drug product process development and manufacturing activities, ensuring high-quality outcomes and adherence to regulatory standards.
BiotechnologyManufacturing
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
ModeX Therapeutics Inc
ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease.
11-50 employees
H1B Sponsorship
ModeX Therapeutics Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
Funding
Current Stage
Early StageTotal Funding
unknown2022-05-09Acquired
Leadership Team
Ji Zhang
Chief Operating Officer
Edward Garmey
Consulting CMO
Recent News
BioWorld Financial Watch
2025-12-19
Labiotech UG
2025-11-08
2025-10-31
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