Senior Project Manager, External Manufacturing
About The Position
Regeneron is seeking a Senior Project Manager to join its External Manufacturing Drug Product team. The position manages a portfolio of molecule-specific programs and ensures External Manufacturing projects are executed in accordance with the overall life cycle management strategy. The role collaborates with cross-functional departments and Contract Manufacturing Organizations (CMOs) to plan, manage, and drive project activities within agreed quality, scope, budget, and timelines. It also builds productive relationships with internal and external stakeholders and ensures high-quality, timely project deliverables. The position leads project teams in a matrix organization and manages projects such as technical transfers, process validation, CMO selection, capital expenditure, life cycle management, and continuous improvement. It manages a team of Project Managers responsible for first-time clinical technical transfers and PPQs through first commercial fills. The role is based in East Greenbush, New York, with a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. and travel of up to 25% domestically and internationally.
Requirements
- Bachelor of Science or Bachelor of Arts in a physical or biological science, plus 12 years of industry-related experience including prior pharmaceutical industry experience and 3 years collaborating with CMOs/CROs, or an equivalent combination of education and experience.
- PMP certification or an MBA.
- Demonstrated leadership managing direct reports.
- Strong project management, interpersonal, cross-cultural, communication, negotiation, attention-to-detail, and problem-solving skills.
- Ingenuity, creativity, and resourcefulness in an evolving and ambiguous environment.
- Ability to listen to team members and stakeholders and foster a productive team environment focused on a common project objective.
- Ability to proactively resolve project issues with tact, diplomacy, and composure.
- Resiliency and flexibility in challenging and adversarial situations.
- Ability to provide clear direction in ambiguous situations and environments.
- Confidence and high emotional intelligence.
- Knowledge of industry regulations such as GxP, ISO, and ICH.
- Ability to apply technical expertise and contribute to the development of new concepts, techniques, and standards.
- Demonstrated experience with project management software and tools.
- Proficiency with advanced techniques in MS Project, Excel, PowerPoint, Word, and shared work environments.
Responsibilities
- Lead cross-functional teams and manage deliverables in a matrix organization to create and execute development strategies for assigned projects, including technical transfers, process validation, new CMO selection, CapEx, life cycle management, and continuous improvement.
- Serve as the single point of contact for project-related communications with CMOs and the CMC Program Manager.
- Drive adherence to project timelines and deliver risk-mitigation strategies for schedule risks.
- Lead multiple projects and priorities using strong organization and time management.
- Plan, track, and deliver project activities, ensuring timely, high-quality delivery.
- Align internal and external team members and stakeholders around a single External Manufacturing project execution plan.
- Organize regular project-focused meetings with CMOs and working teams, including teams for technical transfer, validation, and new product launch.
- Facilitate contingency and risk-mitigation planning and perform project impact assessments.
- Oversee development of integrated project budgets, forecasts, and timelines; monitor progress against approved baselines and manage project KPIs.
- Ensure meeting minutes and action items are published for each project meeting.
- Manage a team of Project Managers overseeing first-time clinical technical transfers and PPQs through first commercial fills.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
