CMC Manager, Technical Operations
ModeX Therapeutics Inc
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Job summary
ModeX Therapeutics Inc. in Boston is seeking a Manager, Technical Operations to lead CMC operational activities across global clinical development.
You will own stability programs, clinical supply strategies, and inventory plans, ensuring alignment with regulatory timelines and product development milestones. You will partner with CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners, driving risk assessments, data review, and continuous improvement while maintaining
Qualifications
- MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related field.
- 5+ years of biopharmaceutical industry experience supporting clinical-stage development (or BS with 10+ years).
- Demonstrated experience leading complex CMC operational activities 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, and working with external partners.
- Proven ability to manage multiple programs and external partners while driving execution.
- Excellent communication and presentation skills for senior leadership.
Responsibilities
- Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution.
- Plan and execute stability programs and shelf-life extension activities with data review, trend analysis, and risk assessments.
- Develop and maintain DP inventory plans and supply strategies for uninterrupted global studies.
- Serve as primary operational lead for testing, stability, and supply chain activities with CDMOs and CROs; ensure alignment on timelines and quality.
- Evaluate analytical and stability data to identify trends and risks; develop mitigation strategies.
- Collaborate with CMC leaders to maintain plans, timelines, dashboards, metrics, and risk registers.
Skills
Education
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- 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.
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