Project Coordinator (Change Control) CMC Program Management

Rensselaer, NY, United States
Sep 20, 2020
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Project Coordinator (Change Control) - CMC Program Management. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Project Coordinator learns and uses prior project management knowledge and experience to thrive in a science driven, multifaceted, innovative environment to help shepherd the development of drugs from preclinical stages to commercialization (bulk drug, drug product devices) to bring drugs to patients in need. We take on big ideas together. The individual uses project management, leadership and matrix management skills to plan and drive progress on critical development activities through various stages of a program lifecycle. The Project Coordinator plans and leads change control activities; including the development and monitoring of program change control schedules within the program strategy plans, managing change control timelines and monitoring activities to closure while cultivating positive relationships with internal and external customers.

As a Project Coordinator, a typical day might include the following:
• Being a liaison between functional areas to support CMC Project planning and being responsible for:
• Coordinating meetings and crafting agendas, minutes and managing action items
• Gathering / compiling data and project information for presentations
• Tracking project results through management of CMC PM tools, e.g. dashboards and MS Project timelines
• Ensuring effective communication of project deliverables up and across the organization
• Utilizing basic project management techniques to identify, develop and maintain best practices, templates and planning tools (spreadsheets, MS Project, etc.) in support of projects and standardization across CMC PM / functional areas
• Developing good communication and working relationships with individuals within each functional group
• Providing support for other functional groups if necessary, e.g. coordination of shipments for product requests, compilation of information for regulatory filings / inspections
• Identifying continuous improvement and lessons learned opportunities to the team; implements solutions with some oversight

This role might be for you if you:
• Enjoy encouraging a positive team culture of ownership and accountability including continuous evaluation, recognition and process improvement
• Excel at proactively identifying issues and providing general guidance on resolving CMC program challenges by developing solutions, and is able to call out appropriately in a timely and effective manner
• Are proactive in trouble shooting and dealing with program, team and cross functional issues.
• Display comfort in various settings.
• Display a proven record of coordinating across multiple teams and driving action and accountability.
• Demonstrate business acuity and successfully engage with higher levels of management as needed.

To be considered for the Project Coordinator you must have a BS/BA in related field and 0-2 years of industry experience, project management experience and CAPM certification a plus. Associate's degree with equivalent experience also considered, or equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.