Senior Manager, Program Management and Drug Substance Lead

Location: Boston, MA preferred

We are seeking a Senior Manager, Program Management & Drug Substance Lead to support execution of drug substance development and manufacturing programs for biologics. This role combines program management with hands-on understanding of CHO-based manufacturing to ensure activities are well-coordinated, risks are proactively managed, and supply aligns with clinical and commercial needs. 

You will play a key role in advancing programs through late-stage development by working across internal teams and external partners to deliver reliable, scalable drug substance supply. 

 

 Roles and Responsibilities 

Program Management & Execution: Drive day-to-day program execution across drug substance activities. Develop and maintain integrated timelines, track deliverables, risks, and dependencies, and ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain teams. 

Drug Substance Development & Manufacturing: Support drug substance activities for biologics, including CHO cell line–based processes. Contribute to process development, tech transfer, scale-up, and manufacturing readiness. Partner with technical teams to ensure processes are robust, scalable, and aligned with program timelines. 

External Manufacturing Coordination: Coordinate activities across CDMOs and external partners. Track manufacturing progress, ensure deliverables meet expectations, and escalate risks or issues as needed. Support preparation for manufacturing campaigns and monitor execution. 

Supply Planning Alignment: Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand. Support planning activities, including production scheduling, inventory tracking, and risk mitigation for supply continuity. 

Risk Management & Issue Resolution: Identify program and technical risks and support development of mitigation plans. Work cross-functionally to resolve manufacturing, process, or supply issues in a timely manner. 

Cross-functional Collaboration: Coordinate across Quality, Regulatory, Clinical, Commercial, and Finance teams to ensure alignment on priorities, timelines, and deliverables. Support regulatory documentation and ensure consistency of CMC information. 

Program & Data Management: Maintain program plans, trackers, and dashboards using tools such as Smartsheet. Ensure timelines, risks, and decisions are accurately captured and communicated through clear updates and reporting. 

 

 Skills and Competencies 

Program Execution: Strong ability to manage timelines, track deliverables, and drive execution in a fast-paced environment. 

Technical Foundation: Working knowledge of biologics drug substance development, including CHO cell culture, upstream and downstream processes. 

Cross-functional Collaboration: Ability to work effectively across teams and manage competing priorities. 

Problem Solving: Strong analytical mindset with the ability to identify risks and support practical solutions. 

Communication: Clear and organized communicator, able to provide concise updates to stakeholders. 

 

Education, Experience and Qualifications 

Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred 

6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management 

Experience with CHO cell-based manufacturing systems required 

Working knowledge of upstream (cell culture) and downstream (purification) processes 

Experience supporting tech transfer, scale-up, and manufacturing execution 

Experience working with external manufacturing partners (CDMOs) 

Strong program management and data management skills; experience with tools such as Smartsheet preferred 

 

 

The salary range for the Senior Manager, Program Management and Drug Substance Lead is expected to be between $155,000 and $175,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.