Senior Project Manager, External Manufacturing

Regeneron Pharmaceuticals, Inc (USA); United States; Sur place; USD 126 000 - 206 000; Plein temps

Avantages offerts par ce poste

annual bonuses or other incentive计划

equity awards

pension or retirement benefits

401(k) company match

health and wellness programs

fitness centers

insurance benefits (e.g. medical, dent

vision, life and disability

paid time off

family support benefits

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, NY, is seeking a Senior Project Manager to lead external manufacturing drug product programs. You will coordinate cross-functional teams, drive lifecycle management, and manage CMOs/CROs to ensure on-time, within-budget deliverables and robust risk mitigation.

The role requires strong leadership, PM expertise, and a track record of delivering complex projects in biopharma, with potential travel and on-site collaboration across global

Qualifications

• BS/BA in physical or biological sciences with 12+ years of industry experience, including pharma collaboration with CMOs/CROs.
• PMP certification or MBA.
• Demonstrated leadership managing direct reports.
• Strong PM, interpersonal, cross-cultural, and communication skills.
• Ability to operate in an evolving, ambiguous environment with ingenuity.
• Proven ability to deliver projects on time and within budget.

Responsabilités

• Lead cross-functional teams in a matrix organization to deliver development strategies for assigned projects (technical transfers, process validation, CMOs selection).
• Act as single point of contact for project communications with CMOs and CMC Program Manager.
• Drives adherence to timelines and risk mitigation strategies; manages budgets, forecasts and KPIs.
• Oversee a team of Project Managers handling first-time clinical transfers and PPQs through initial commercial fills.

Connaissances

Leadership

Project management

Cross-cultural communication

Risk management

Strategic thinking

Problem-solving

Stakeholder management

Formation

BS/BA in physical or biological sciences

PMP certification or MBA

12+ years industry experience

Outils

MS Project

Excel

PowerPoint

Word

Description du poste

Build our future together: 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:

Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm
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. Organises 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.

Required Qualifications:

• 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 a degree of ingenuity, creativity and resourcefulness in an evolving and ambiguous environment.
• Understanding and listening 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.

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

Salary Range (annually) $126,300.00 - $206,100.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Employment Opportunity Statement:

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, and 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.