Project Manager, External Manufacturing (CMO Site Selection)

Regeneron Pharmaceuticals • Valley, AL

8d • $92,200 - $176,000 • Onsite

About The Position

We are currently looking to fill a Project Manager position within our External Manufacturing organization. Using strong project management experience and knowledge of external manufacturing, the Project Manager is responsible for evaluating and leading technology transfer projects from IND Project Approval (IPA) through Contract Manufacturing Organization (CMO) selection, as well as providing flexible project management support across the External Manufacturing portfolio. This role collaborates with cross-functional departments and CMOs to plan, manage, and drive project activities within agreed quality, scope, budget, and time. Builds and maintains productive relationships with a wide variety of internal and external stakeholders and ensures superior quality and timeliness of project deliverables.

Requirements

• Strong project management, interpersonal, cross-cultural communication, negotiation, and problem-solving skills.
• Ingenuity, creativity, and resourcefulness in a sometimes evolving and ambiguous environment.
• Ability to provide clear direction to others in ambiguous situations and environments.
• Ability to drive proactive resolution of project-related issues with tact, diplomacy, and composure.
• Resiliency and flexibility in the face of challenges and adversarial situations.
• Ability to understand and listen to team members and stakeholders while fostering a productive team environment toward one common project objective.
• Confidence and a high emotional IQ.
• Knowledge of industry practices and regulations (e.g., GxP, ISO, ICH, etc.).
• Technical expertise that contributes to the development of new concepts, techniques, and standards.
• Proficiency in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc., in addition to experience working within shared work environments.
• Bachelor’s degree in any physical or biological science and 10 years of industry related experience, including prior pharmaceutical industry experience.
• May substitute proven experience for education requirement.

Responsibilities

• Leads the evaluation and execution of technology transfer projects from IND Project Approval (IPA) through CMO selection, ensuring alignment with the overall life cycle management strategy.
• Manages the planning and execution of deliverables for assigned External Manufacturing projects related to molecule-specific programs, including Technical Transfers, Process Validation, new CMO selection, and CapEx.
• Acts as single point of contact for assigned project-related communications with CMOs and internal Regeneron stakeholders, including the CMC Program Manager.
• Leads cross-functional teams and prioritizes project activities using excellent organizational, communication, and time management skills.
• Ensures teams and stakeholders are aligned on one single External Manufacturing project plan.
• Plans and tracks project activities, coordinating contingency and risk mitigation planning throughout the project lifecycle.
• Facilitates regular project-focused meetings with CMOs and working teams (technical transfer, validation, new product launch, etc.).
• Ensures meeting minutes and weekly/monthly reports are completed and distributed accurately.
• Provides flexible project management support across the External Manufacturing portfolio as business needs evolve.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level