Associate Director of CMC, Drug Product at ModeX Therapeutics

Weston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Mar, 26

Salary

0.0

Posted On

23 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Drug Product Process Development, Antibody Conjugation Chemistry, Lipid Nanoparticle Formulation, Analytical Characterization, Technology Transfer, Scale-Up, Manufacturing, Regulatory Compliance, Project Leadership, Cross-Functional Collaboration, Troubleshooting, Process Improvements, Documentation Skills, Experimental Design, Downstream Purification, Design of Experiments

Industry

Biotechnology Research

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 1. Ph.D. with 5+ years of relevant industry experience 2. 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. Qualifications 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.

Responsibilities

The Associate Director will lead external drug product process development and manufacturing activities for multispecific antibody and LNP-based programs, ensuring high-quality and timely delivery. They will also manage technology transfer and troubleshoot technical issues while supporting strategic planning for platform advancement.