Regeneron
BIOTECHNOLOGY
Small Molecules, Biologics
LocationTARRYTOWN, NY
Employees13,000
Open Jobs436
Pipeline
Sodium-glucose cotransporter 2 inhibitorsN/A
Non-interventionalN/A
There is no interventionN/A
Non-InterventionalN/A
Project Manager, External Manufacturing (CMO Site Selection)
Regeneron
This listing was originally posted on Regeneron's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moWe are currently looking to fill a Project Manager position within our External Manufacturing organization. Using strong project management experience and knowledge of external manufacturing, the Project Manager is responsible for evaluating and leading technology transfer projects from IND Project Approval (IPA) through Contract Manufacturing Organization (CMO) selection, as well as providing flexible project management support across the External Manufacturing portfolio. This role collaborates with cross-functional departments and 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 and ensures superior quality and timeliness of project deliverables.
In this role, a typical day might include the following:
Leads the evaluation and execution of technology transfer projects from IND Project Approval (IPA) through CMO selection, ensuring alignment with the overall life cycle management strategy.
Manages the planning and execution of deliverables for assigned External Manufacturing projects related to molecule-specific programs, including Technical Transfers, Process Validation, new CMO selection, and CapEx.
Acts as single point of contact for assigned project-related communications with CMOs and internal Regeneron stakeholders, including the CMC Program Manager.
Leads cross-functional teams and prioritizes project activities using excellent organizational, communication, and time management skills.
Ensures teams and stakeholders are aligned on one single External Manufacturing project plan.
Plans and tracks project activities, coordinating contingency and risk mitigation planning throughout the project lifecycle.
Facilitates regular project-focused meetings with CMOs and working teams (technical transfer, validation, new product launch, etc.).
Ensures meeting minutes and weekly/monthly reports are completed and distributed accurately.
Provides flexible project management support across the External Manufacturing portfolio as business needs evolve.
This role might be for you if you have:
Strong project management, interpersonal, cross-cultural communication, negotiation, and problem-solving skills.
Ingenuity, creativity, and resourcefulness in a sometimes evolving and ambiguous environment.
Ability to provide clear direction to others in ambiguous situations and environments.
Ability to drive proactive resolution of project-related issues with tact, diplomacy, and composure.
Resiliency and flexibility in the face of challenges and adversarial situations.
Ability to understand and listen to team members and stakeholders while fostering a productive team environment toward one common project objective.
Confidence and a high emotional IQ.
Knowledge of industry practices and regulations (e.g., GxP, ISO, ICH, etc.).
Technical expertise that contributes to the development of new concepts, techniques, and standards.
Proficiency in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc., in addition to experience working within shared work environments.
To be considered for this role you must hold a Bachelor’s degree in any physical or biological science and the following amount of industry related experience, including prior pharmaceutical industry experience for each level:
Associate Project Manager: 8 years
Project Manager: 10 years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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BIOTECHNOLOGY
Small Molecules, Biologics
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