Project Manager External Manufacturing, Drug Product

Regeneron Pharmaceuticals, Inc.; New York; On-site; USD 110,000 - 170,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Drug Product Project Manager to join the External Manufacturing Drug Product team in East Greenbush, NY.

The role focuses on managing molecule-specific programs within a lifecycle management framework and coordinating with CMOs to deliver projects on scope, quality and schedule. The DP PM will lead cross-functional teams, coordinate communications, and drive project plans while managing risks and stakeholder expectations.

Qualifications

• BS/BA in physical or biological science with 8+ years of pharmaceutical industry experience for Associate PM or 10+ years for PM
• Experience managing molecule-specific drug product programs and coordinating with CMOs
• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills
• Knowledge of GxP, ISO, ICH guidelines and (preferred) PMP or MBA
• Proficiency with MS Project, Excel, PowerPoint, Word and working in shared work environments

Responsibilities

• Leads cross-functional teams and plans for molecule-specific drug product programs (Tech Transfers, Process Validation, CMO selection, CapEx, Life Cycle Management, continuous improvement)
• Acts as single point of contact for project communications with CMOs and CMC Program Manager
• Drives project execution with strong organizational and time-management skills
• Ensures alignment on a single drug product project plan across teams and stakeholders
• Plans, tracks and documents project activities; facilitates regular project-focused meetings
• Coordinates contingency and risk mitigation planning and ensures accurate meeting minutes and reports

Skills

Project management

Cross-functional leadership

Communication

Negotiation

Problem-solving

Team 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 Project Manager position to join our External Manufacturing Drug Product team. Using strong project management experience and knowledge of product manufacturing, the Drug Product Project Manager (DP PM) is responsible for managing at least one molecule-specific program to ensure that drug product projects are being executed according to an overall life cycle management strategy. The DP PM 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. Builds and maintains productive relationships with a wide variety of internal and external stakeholders. Ensures 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%

Discover your role:

• Leads cross-functional teams and manages the planning and execution of deliverables for the assigned Drug Product projects related to the development strategy for at least one molecule-specific program (i.e.- 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.
• Leads projects and prioritizes using excellent organizational, communication and time management skills.
• Ensures teams and stakeholders are aligned on one single drug product manufacturing project plan.
• Plans and tracks the project activities.
• Facilitates regular project focused meetings with CMO and working teams (technical transfer, validation, new product launch, etc.).
• Coordinates contingency and risk mitigation planning for projects.
• Ensures meeting minutes and weekly/monthly reports are completed accurately.

This role requires:

• BS/BA in any physical or biological science and the following amount industry related experience, including prior pharmaceutical industry experience, or equivalent combination of education and experience, for each level: Associate Project Manager - 8+ years
• Project Manager - 10+ years
• Level to be determined based on qualifications relevant to the role
• PMP certification or MBA a plus.
• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills.
• Exhibits a degree of ingenuity, creativity and resourcefulness in a sometimes 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 practices and regulations (e.g. GxP, ISO, ICH, etc.).
• Applies technical expertise (in their area) and may contribute to the development of new concepts, techniques and standards.
• 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.

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