Manager, Technical Operations

ModeX Therapeutics Inc.; Weston, Northern (MA, KY); Hybrid; USD 135,000 - 150,000; Full time

Job summary

ModeX Therapeutics in Weston, MA is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply activities across global programs. The role owns key processes related to stability, supply chain, and outsourcing, ensuring quality and timely delivery.

The ideal candidate will oversee risk management, continuous improvement, and collaboration with internal teams and external partners.

Qualifications

• Advanced degree in life sciences with relevant clinical-stage CMC experience.
• Experience leading complex CMC operational activities in regulated settings.
• Knowledge of biologics development, clinical manufacturing, analytical testing, and stability.
• Experience with budget management, forecasting, and vendor partnerships.

Responsibilities

• Lead CMC operational activities across drug product, analytical, stability, packaging, and logistics.
• Plan and execute stability programs, data review, trend analysis, and risk assessments.
• Develop DP inventory plans and supply strategies for global clinical studies.
• Coordinate with CDMOs, CROs, and partners to ensure timelines and quality.
• Monitor performance, resolve issues, and support leadership reviews.
• Maintain CMC plans, dashboards, metrics, and risk registers for decision-making.
• Lead operational readiness for analytical testing and clinical supply production.

Skills

CMC operations leadership

Cross-functional coordination

Budget management and forecasting

Project management

Regulated environment experience

Education

MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or related discipline

BS in a related scientific discipline with 10+ years of industry experience

Job description

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.

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.
• Lead CMC budget tracking, forecasting, purchase order management, and expenditure reporting, providing financial visibility and recommendations to leadership.
• 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, Finance, 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.
• Experience with budget management, forecasting, resource planning, and financial tracking.
• 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.

ModeX Therapeutics is an Equal Opportunity Employer

Pay Range

Pay Range

The actual pay rate will depend on the person's qualifications and experience. $135,000.00 - $150,000.00 / year

Pay Transparency

In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.

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