Project Manager External Manufacturing, Drug Product
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
Requirements
- BS/BA in any physical or biological science
- 10+ years industry related experience, including prior pharmaceutical industry experience
- Strong project management skills
- Strong interpersonal, cross-cultural, communication, negotiation and problem-solving skills
- Knowledge of industry practices and regulations (e.g. GxP, ISO, ICH)
- Proficient with MS Project, Excel, PowerPoint, Word
- PMP certification or MBA a plus
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.