CMC Manager, Technical Operations

BioSpace; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

ModeX Therapeutics, an OPKO Health company, is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply across global programs. This role serves as the functional owner for stability and supply chain processes, driving risk management, continuous improvement, and alignment among internal and external stakeholders.

Strong technical judgment and dedication to quality are essential.

Qualifications

• Demonstrated experience leading complex CMC operational activities within a regulated environment.
• Experience coordinating with CDMOs, CROs, and external partners to meet timelines and quality targets.
• Strong project management, organizational skills, and ability to influence cross-functional teams.

Responsibilities

• Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution functions.
• Lead planning and execution of stability programs and shelf-life extension activities with data review and risk mitigation.
• Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
• Serve as the primary operational lead for testing, stability, and supply chain activities at external partners, ensuring alignment on timelines and quality.
• Collaborate with CMC leaders to maintain operational plans, dashboards, risk registers, and management reporting.
• Lead operational readiness activities for analytical testing, clinical supply production, and distribution activities.
• Drive continuous improvement initiatives focused on operational efficiency, data management, and documentation practices.

Skills

CMC operations

Cross-functional leadership

Biopharmaceuticals

Project management

Regulated environment

Stability programs

Analytical thinking

Education

MS or PhD in Pharmaceutical Sciences or related

5+ years in biopharmaceutical clinical development (or BS +10 years)

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

The Manager, Technical Operations provides operational leadership for CMC development and clinical supply activities across global development programs. This individual serves as the functional owner for key Technical Operations outsourced and in-house processes, including stability and supply chain activities, while driving cross-functional alignment among internal and external stakeholders. The role is responsible for operational planning and execution including risk management and continuous improvement initiatives that support the successful CMC development and supply of clinical-stage products. This is a manager-level individual contributor position requiring strong technical judgment, commitment to quality, and the ability to influence outcomes. The ideal candidate is highly organized, detail-oriented, data-driven, and committed to operational excellence and accuracy.

Why Join Us

In this job you will play a pivotal role in advancing innovative biologic therapies from development through clinical execution. This is an opportunity to build and lead stability and clinical supply strategies that directly influence product development, regulatory milestones, and patient access to investigational therapies.

What Makes This Role Unique

High-impact decision making

• Lead stability programs, shelf-life assessments, and clinical supply strategies that directly influence development timelines and clinical trial success.
• Use scientific and operational judgment to guide critical decisions on inventory utilization, expiration dating, and supply continuity.

Broad visibility and influence

• Partner closely with senior leaders across CMC, Quality, Regulatory Affairs, Clinical Operations, and external development partners.
• Present recommendations and risk assessments that shape program strategy and business decisions.

Ownership across the product lifecycle

• Drive stability and clinical supply activities from early clinical development through late-stage programs.
• Lead initiatives spanning analytical testing, stability studies, packaging, labeling, global distribution, and inventory management.

Work on innovative therapies

• Support cutting-edge biologic development programs addressing significant unmet patient needs.
• Contribute to complex development challenges involving novel modalities, cold-chain logistics, and global clinical supply networks.

A collaborative and entrepreneurial environment

• Join a growing organization where expertise, initiative, and problem-solving are highly valued.
• Work in a highly cross-functional setting where individuals are empowered to make meaningful contributions and drive change.

Professional growth

• Expand your technical and strategic leadership capabilities through exposure to multiple development programs, regulatory interactions, and global clinical operations.
• Build a foundation for future leadership opportunities across Technical Operations, CMC, Supply Chain, and Product Development.

Who Will Thrive Here

This role is ideal for candidates who enjoy combining scientific rigor with operational leadership, are energized by solving complex development challenges, and want to make a visible impact on the advancement of innovative therapies and clinical programs.

Core Responsibilities

• Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/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 to support program decisions.
• Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
• Serve as the primary operational lead for testing, stability, and supply chain activities at CDMOs, CROs, and other external partners, ensuring alignment on timelines, deliverables, and quality expectations. Monitor partner performance, facilitate issue resolution, and support business reviews to drive operational excellence.
• Evaluate analytical and stability data to identify trends, assess operational and technical risks, and develop mitigation strategies to support program success.
• Collaborate with CMC leaders to maintain CMC operational plans, timelines, dashboards, metrics, risk registers, and management reporting to support informed and proactive decision-making.
• Lead operational readiness activities for analytical testing, clinical supply production, and distribution activities.
• 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 impact project timelines or clinical supply availability.
• Collaborate with CMC, Clinical Operations, Program Management and external partners to track deliverables, communicate status, and elevate issues to leadership.
• Support CMC activities by preparing program updates, risk assessments, mitigation plans, and decision-support materials for leadership and cross-functional teams.

Qualifications

• MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related scientific discipline, with 5+ years of biopharmaceutical industry experience supporting clinical-stage development programs; or a BS in a related scientific discipline with 10+ years of relevant industry experience.
• Demonstrated experience leading complex CMC operational activities and cross-functional initiatives within 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.
• Proven 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, with the ability to facilitate alignment across diverse stakeholder groups.
• Excellent communication and presentation skills, including experience presenting recommendations and program status to senior leadership.