Senior Project Manager, External Manufacturing

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 126,000 - 206,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life & disability insurance

Paid time off

Holiday leave

Wellness program

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Project Manager for the External Manufacturing Drug Product team in the United States. The role manages a portfolio of molecule-specific programs, coordinating with CMOs and internal teams to deliver on time, within scope and budget.

The candidate will lead cross-functional teams, drive risk mitigation, and ensure a single integrated project plan across multiple projects, including technical transfers and process validation.

Qualifications

• BS/BA in physical or biological science; 12+ years in industry
• PMP or MBA required
• Experience collaborating with CMOs/CROs and managing external manufacturing programs

Responsibilities

• Leads cross-functional teams in a matrix organization to execute development strategy (Technical Transfers, Process Validation, CMO selection, CapEx, Life Cycle Management).
• Acts as single point of contact for project communications with CMOs and CMC Program Manager.
• Drives adherence to timelines and risk mitigation strategies; manages multiple projects and priorities.
• Organizes regular project meetings with CMOs and internal teams; ensures aligned External Manufacturing project execution plan.

Skills

PMP certification

MBA

Project management

Cross-functional collaboration

GxP knowledge

MS Project

Excel

Communication

Education

BS/BA in physical or biological science

Tools

MS Project

Excel

PowerPoint

Word

Job description

Team: Industrial Operations & Product Supply

Senior Project Manager, External Manufacturing

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Senior Project Manager position to join our External Manufacturing Drug Product team. 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. Also, builds and maintains productive relationships with a wide variety of internal and external stakeholders while ensuring superior quality and timeliness of project deliverables.

When & where:

• Travel requirement: Up to 25%, international and domestic

Discover your role:

• Leads cross-functional teams and manages the deliverables in a matrix organization to create, and execute to the development strategy for the assigned projects (Technical Transfers, Process Validation, new CMO selection, CapEx, Life Cycle Management and Continuous Improvement).
• Acts as single point of contact for assigned project related communications with CMOs and CMC Program Manager.
• Drives strong adherence to project management timelines and delivers on risk mitigation strategies to 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 one single External Manufacturing project execution plan.
• Organizes regular project focused meetings with CMO and working teams (technical transfer, validation, new product launch, etc.).
• Facilitates contingency and risk mitigation planning and performs impact assessments for projects.
• Oversees the development of the integrated project budgets, forecasts and timelines and is accountable to monitor progress against the approved baselines and manage project KPIs.
• Ensures meeting minutes and action items published for each project meeting.
• Manage a team of Project Managers who manage first time clinical technical transfers as well as PPQs through first commercial fills.

This role requires:

• BS/BA in 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.
• Strong project management, interpersonal, cross-cultural, communication, negotiation, attention to detail, and problem-solving skills.
• Exhibits a degree of ingenuity, creativity and resourcefulness in an evolving and ambiguous environment.
• Understands and listens to team members and stakeholders while fostering a productive team environment to one common project objective.
• Drives for 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.

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$126,300.00 - $206,100.00

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Hear about new opportunities and stories across our teams.