Sr Program Manager

Overview

The Sr Manager is responsible for leading complex product development and manufacturing programs within our Contract Development and Manufacturing Organization (CDMO). Acting as the primary client interface for program execution, this individual ensures programs are delivered within scope, schedule, and budget while meeting quality and regulatory requirements. This role requires a hands-on leader who combines strong financial acumen, technical program management expertise, and client engagement skills.

The Senior Program Manager will lead cross-functional teams across R&D, Operations, Manufacturing, Supply Chain, and Quality, driving program execution from initiation through closure. The position is accountable for project financial performance, proactive risk management, and fostering long-term client relationships by consistently delivering results.

• Serve as the primary client interface throughout program execution, maintaining effective communication and professional relationships.
• Manage programs from initiation through closure, including planning, feasibility, development, verification and transfer phases.
• Lead cross-functional teams spanning R&D, Manufacturing, Supply Chain, Quality, and Operations.
• Ability to navigate complex environments and manage diverse groups of stakeholders, ensuring alignment internally and with the client.
• Establish and facilitate project kickoff, phase-gate reviews, design reviews, and client and internal status meetings.
• Develop and manage detailed project plans, schedules, and deliverables, with clear milestones and dependencies.
• Monitor scope, schedule, and resources, escalating issues and developing contingency plans as needed.
• Report program status, financial performance, risks, and opportunities to executive management and clients with transparency.
• Own program’s financial performance, including revenue, gross margin, change order management, and cash flow.
• Develop and analyze monthly forecasts ensuring target accuracy is obtained. Proactively communicate risks and apply lessons learned to future forecast periods to improve accuracy.
• Ensure project execution in alignment with company Quality Management System (QMS), design controls, and applicable regulatory standards (e.g., FDA, ISO).
• Participate in client and regulatory audits as a program representative.
• Identify and actively manage risks and opportunities, implementing response plans and mitigations proactively.
• Provide clear, proactive communication to clients regarding technical progress, schedule, budget, risks, and mitigations.
• Maintain client satisfaction by delivering commitments according to agreed upon success criteria. Build trust through transparency and accountability.
• Collaborate with Business Development to ensure continuity between sales objectives and program execution, supporting scope and budget change discussions as needed.
• Support Business Development with scoping new client projects regarding technical requirements, assumptions, deliverables, schedule, resources, and budget, as needed.
• Contributing to success of the PMO by going beyond execution into recognizing patterns, improving processes, and sharing best practices.
• Drive standardization of tools and processes, using metrics to measure impact to guide improvement.
• Incorporate post-mortems and feedback into future planning to strengthen program execution.

Education:
Bachelor’s degree in engineering, life sciences, or related field (advanced degree a plus).

Experience:
10+ years of program/project management experience in a CDMO, medical device, biotech, or regulated manufacturing environment.

Essential Knowledge, Skills & Abilities:

• Demonstrated leadership skills.
• Knowledge of standard Project Management processes and methods.
• Ability to “get things done” in a growing organization – willingness to fill gaps and wear multiple hats.
• Understanding of product development and manufacturing for regulated medical products.
• Ability to create and manage complex schedules with detailed work breakdown structures.
• Ability to create and manage program budgets.
• Excellent interpersonal skills for…