Associate Director of CMC, Drug Product
Company: Modex Therapeutics Ltd.
Location: Weston
Posted on: January 9, 2026
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Job Description:
Company Overview ModeX Therapeutics, an OPKO Health company, is
the leading clinical-stage biopharmaceutical company developing
unique and proprietary-multispecific therapeutics. Its MSTAR
platform unites the power of multiple biologics in a single
molecule to create multispecific antibodies that bind four or more
targets with unprecedented versatility and potency for complex
diseases. Its promising first-in-class immunology pipeline includes
candidates against immune diseases, including cancer (both solid
and hematologic tumors), immune impairment, as well as several of
the world's most pressing viral threats. Its founding team includes
globally recognized medical innovators with proven track records of
delivering breakthroughs for patients. ModeX is based in Weston,
Massachusetts. For more information, please visit www.modextx.com .
Job Description 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. Key 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. Qualifications: 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: 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.
Keywords: Modex Therapeutics Ltd., Hartford , Associate Director of CMC, Drug Product, Science, Research & Development , Weston, Connecticut
