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Project Associate _ CMC Program Management

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Aug 28, 2021

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Discipline
Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are currently looking to fill a Project Associate (Change Control) - CMC Program Management position with a first shift Monday through Friday work week. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Project Associate 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 Change Control Project Associate 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 Change Control Project Associate, a typical day might include the following:

  • Being a liaison between functional areas to support CMC Project planning and being responsible for:
    • Organizing meetings and creating agendas, minutes and managing action items
    • Gathering / compiling data and project information for presentations
    • Tracking project deliverables through management of CMC PM tools, e.g. dashboards and MS Project timelines
    • Ensuring effective communication of project deliverables up and across the organization
    • Identifying risk and developing mitigation strategies with input from manager
  • Utilizes project management best practices to ensure projects meet scope, budget, and timeline while ensuring quality.
  • Works closely with direct manager to develop and communicate integrated CMC strategy to management and the business.
  • Works independently to obtain buy-in of strategy with CMC team.
  • Serves as primary point of contact between cross-functional areas to facilitate the advancement of projects.
  • Proactively identifies team performance issues and works to resolve with input from manager.
  • Utilizes 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
  • Leverages proficient understanding of CMC PM processes and tools to manage project work
  • Develops excellent communication and working relationships with individuals within each functional group, including department leaders
  • Identifies continuous improvement and lessons learned opportunities to the team and implements solutions

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 Associate, CMC Program Management, you should have a BS/BA in related field and of 3+ years of industry experience (project management experience or MBA a plus), equivalent combination of education and experience.

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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