Manager, Technical Operations

ModeX Therapeutics•Weston, MA

About The Position

The Manager, Technical Operations provides operational leadership for CMC development and clinical supply activities across global development programs. The role serves as functional owner for key outsourced and in-house Technical Operations processes, including stability and supply chain activities, and drives alignment among internal and external stakeholders. It is a manager-level individual contributor position requiring technical judgment, a commitment to quality, and the ability to influence outcomes. The position oversees operational planning and execution, risk management, and continuous improvement supporting CMC development and clinical supply of clinical-stage products. The role leads stability programs, shelf-life assessments, and clinical supply strategies that inform development timelines and clinical trial success. It partners with leaders across CMC, Quality, Regulatory Affairs, and Clinical Operations, as well as external development partners, and presents recommendations and risk assessments to support program and business decisions. Responsibilities span analytical testing, stability studies, packaging, labeling, global distribution, and inventory management, from early clinical development through late-stage programs. The position supports biologic development programs involving novel modalities, cold-chain logistics, and global clinical supply networks.

Requirements

MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related scientific discipline, with at least 5 years of biopharmaceutical industry experience supporting clinical-stage development programs; alternatively, a BS in a related scientific discipline with at least 10 years of relevant industry experience.
Demonstrated experience leading complex CMC operational activities and cross-functional initiatives in a regulated environment.
Understanding of biologics development, clinical manufacturing, analytical testing, stability programs, and clinical supply operations.
Experience supporting clinical supply planning, inventory management, batch disposition activities, and external development and manufacturing partners.
Ability to independently manage multiple programs, priorities, and external partners while driving execution against established objectives.
Experience reviewing and interpreting technical documentation, manufacturing records, protocols, reports, investigations, and change controls to identify risks and develop practical mitigation strategies.
Strong project management, organizational, and influencing skills, including the ability to facilitate alignment across diverse stakeholder groups.
Excellent communication and presentation skills, including experience presenting recommendations and program status to senior leadership.
Highly organized, detail-oriented, data-driven, and committed to operational excellence and accuracy.

Responsibilities

Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging and labeling, storage, logistics, and distribution functions.
Lead planning and execution of stability programs and shelf-life extension activities, including data review, trend analysis, risk assessment, and recommendations.
Develop and maintain drug product inventory plans and supply strategies to support global clinical studies without interruption.
Serve as the primary operational lead for testing, stability, and supply chain activities at CDMOs, CROs, and other external partners; align timelines, deliverables, and quality expectations; monitor partner performance; resolve issues; and support business reviews.
Evaluate analytical and stability data to identify trends, assess operational and technical risks, and develop mitigation strategies.
Collaborate with CMC leaders to maintain operational plans, timelines, dashboards, metrics, risk registers, and management reporting.
Lead operational readiness activities for analytical testing, clinical supply production, and distribution.
Drive continuous improvement initiatives focused on operational efficiency, data management, business processes, and documentation practices.
Identify, assess, and proactively manage supply chain challenges and operational issues that may affect project timelines or clinical supply availability.
Collaborate with CMC, Clinical Operations, Program Management, and external partners to track deliverables, communicate status, and escalate issues to leadership.
Prepare program updates, risk assessments, mitigation plans, and decision-support materials for leadership and cross-functional teams.