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About the Role

This role is responsible for managing a portfolio of molecule-specific programs to ensure that External Manufacturing projects are being executed according to an overall life cycle management strategy. The role collaborates with cross-functional departments as well as Contract Manufacturing Organizations (CMOs) to plan, manage and drive project activities within agreed quality, scope, budget and time.

Responsibilities

• Leads cross-functional teams and manages deliverables in a matrix organization to create and execute development strategies for assigned projects.
• Acts as the single point of contact for assigned project-related communications with CMOs and the CMC Program Manager.
• Drives adherence to project management timelines and delivers on risk mitigation strategies for timeline risks.
• Leads multiple projects and priorities with excellent organizational and time management skills.
• Plans, tracks, and delivers project activities with demonstrated experience of on-time and high-quality project delivery.
• Ensures all internal and external team members and stakeholders are aligned on a single External Manufacturing project execution plan.
• Organizes regular project-focused meetings with CMOs and working teams.
• Facilitates contingency and risk mitigation planning and performs impact assessments for projects.
• Oversees the development of integrated project budgets, forecasts, and timelines, monitoring progress against approved baselines and managing project KPIs.
• Ensures meeting minutes and action items are published for each project meeting.
• Manages a team of Project Managers responsible for clinical technical transfers and PPQs through first commercial fills.

Requirements

• BS/BA in any physical or biological science and 12 years of industry-related experience, including prior pharmaceutical industry experience and 3 years of experience collaborating with CMOs/CROs, or equivalent combination of education and experience.
• PMP certification or MBA.
• Demonstrated leadership managing direct reports.
• Strong project management, interpersonal, cross-cultural, communication, negotiation, attention to detail, and problem-solving skills.
• Exhibits ingenuity, creativity, and resourcefulness in an evolving and ambiguous environment.
• Understands and listens to team members and stakeholders while fostering a productive team environment.
• Drives proactive resolution of project-related issues with tact, diplomacy, and composure.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Ability to provide clear direction to others in ambiguous situations and environments.
• Exhibits confidence and a high emotional IQ.
• Knowledge of industry regulations (e.g., GxP, ISO, ICH, etc.).
• Applies technical expertise and contributes to the development of new concepts, techniques, and standards.
• Demonstrated experience with project management software and tools.
• Proficient in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc., in addition to experience working within shared work environments.

Skills

• Project Management
• Interpersonal Skills
• Cross-cultural Communication
• Negotiation
• Attention to Detail
• Problem-Solving
• Organizational Skills
• Time Management
• Leadership
• MS Project
• Excel
• PowerPoint
• Word

Location

• East Greenbush, New York, United States

Work Type

• On-site

Experience Level

• Senior

Education Level

• BS/BA
• PMP Certification
• MBA

Salary/Compensations

• $126,300.00 - $206,100.00

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g., medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We are committed to building a workplace with an inclusive culture.
• We believe we do our best work when we are together.

Equal Opportunity

• Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.