Senior Project Manager, External Manufacturing

BioSpace; Town of East Greenbush (NY); On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron is seeking a Senior Project Manager to join our External Manufacturing Drug Product team in East Greenbush, NY. You will manage a portfolio of molecule-specific programs, collaborating with CMOs to plan, execute and optimize lifecycle management strategies.

The role requires strong leadership, cross-functional coordination, and a track record of delivering projects on time and within scope. Travel is up to 25%.

Qualifications

• BS/BA in physical or biological science with 12 years of industry experience, including pharma collaboration with CMOs/CROs.
• PMP certification or MBA required.
• Demonstrated leadership managing direct reports.

Responsibilities

• Leads cross-functional teams to execute development strategy for assigned projects.
• Acts as single point of contact for CMOs and the CMC Program Manager.
• Drives adherence to timelines and mitigates risks.
• Plans, tracks, and delivers project activities with on-time, high-quality results.
• Oversees budgets, forecasts, timelines and KPIs.
• Organizes regular project meetings with CMOs and internal teams.

Skills

Leadership

Communication

Negotiation

Attention to detail

Problem solving

Time management

Cross-cultural collaboration

Risk management

Education

BS/BA in physical or biological science

Tools

MS Project

Excel

PowerPoint

Word

Job description

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.
• 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.
• 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.
• 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.

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.

Salary Range (annually)

$126,300.00 - $206,100.00

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

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.