About this role

Job Summary

The Manager, Technical Operations is responsible for executing CMC operational activities supporting global clinical development programs. This role provides coordination, tracking, documentation, data management, and operational support across manufacturing, testing, stability, clinical supply, and external partner activities. The ideal candidate is highly organized, detail-oriented, data-driven, and committed to operational excellence and accuracy.

Core Responsibilities

· Execute and coordinate stability studies at external vendors and support shelf-life extension activities, including data review, trending, and documentation.

· Compile, monitor, trend, and verify analytical, manufacturing, and stability data to support decision-making and identify potential risks.

· Coordinate CMC operational activities across manufacturing, testing, packaging/labeling, storage, logistics, and distribution sites supporting global clinical programs.

· Support drug substance and drug product manufacturing activities, review of batch documentation, and coordinate clinical supply activities

· Prepare and maintain operational dashboards, metrics, timelines, trackers, and status reports to support program execution.

· Support continuous improvement initiatives related to operational efficiency, data management, documentation, and business processes.

· Collaborate with CMC, Clinical Operations, Program Management, Finance, and external partners to track deliverables, communicate status, and escalate issues.

· Support budgeting, forecasting, purchase order management, invoice processing, and tracking of CMC expenditures.

Qualifications

· Advanced degree in Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or related discipline with 5+ years of relevant industry experience.

· Demonstrated ability to analyze and trend technical data and translate findings into actionable recommendations.

· Experience supporting operations within a GxP environment and proven ability to work effectively across Quality, Manufacturing, and Technical Development functions.

· Exceptional attention to detail, organizational skills, and commitment to accuracy.

· Excellent communication, documentation, and project management skills.

· Experience coordinating activities across external vendors, CDMOs, CROs, and testing laboratories.

· Experience managing technical documentation, operational trackers, and data reporting within a regulated environment.

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.