We are currently looking to fill a Project Specialist, External Manufacturing position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Using project management techniques and experience to support well defined External Manufacturing Serialization projects to support the overall portfolios managed by the Serialization Managers. Additionally, you may also support, plan, and coordinate operational tasks under the guidance of Serialization Manager..
As a Project Specialist, a typical day might include the following:
Functioning as a project support or lead for more than one well defined EM serialization projects in the European Union and United States
Supporting or leading daily operational tasks including data errors, alerts, and data modifications to ensure commercial drug supply is not impacted
Maintaining and executing EM serialization project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned EM Project
Utilizing basic project management techniques to identify, develop and maintain planning tools (Spreadsheets, MS Project etc.) in support of projects in order to facilitate standardization and coordination across functional areas.
Developing working relationships with department leaders, line managers and individuals within each functional group utilizing open communication skills.
Implementing tools used by the EM Project team(s)
Identifying and implementing additional solutions in order to improve information sharing processes as required
Assisting with compiling information for regulatory filings
Aiding with other projects as assigned by Manager
This role might be for you if:
You are action oriented and well organized
You demonstrate strong written, verbal, and interpersonal communication skills with the ability to effectively interact with team members with tact and diplomacy
You can handle multiple priorities/tasks with strong time management skills
To be considered for this opportunity you should have the following:
Associate Specialist: Requires BS/BA in scientific subject area.
Specialist: Requires BS/BA in scientific subject area and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
Senior Specialist: Requires BS/BA in scientific subject area and 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
Experience with European Medicines Directive or DSCSA a plus.
CAPM, PMP certification or MBA a plus.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)