Associate Manager, CMC Project Management

Rensselaer, New York, US
Oct 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Using project management knowledge within the drug development industry, the Associate Manager plans, coordinates and leads the progress of assigned CMC Projects of moderate scope as established by defined milestones and objectives.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Functions as a liaison or lead between functional areas in order to facilitate the advancement of cross-functional CMC Projects through the pipeline. Provides support to supervisor in assessing resource needs to achieve project timelines and quality milestones.

• Creates, maintains and executes CMC Project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned CMC Project.

• Coordinates and leads communication between global functional areas and corporate partners where applicable. Coordinates activities for writing data summaries or presentations for joint collaboration meetings, etc.

• Ensures effective, accurate and timely communication across functional areas and corporate partners within the CMC Project/Program, serving as a primary point of contact among functional areas for CMC Project-related issues. Communication responsibilities include but not limited to Manage Supply, weekly/monthly project updates as well as TMPs. Works with the supervisor/Department Director to identify and resolve any team and individual performance issues.

• Assesses CMC Project issues and develops solutions to meet productivity and quality milestones and objectives. Develops tools and mechanisms for monitoring progress and problem solving with CMC Project and functional area managers. Defines and documents working / best practices that can be used across other CMC Projects with all relevant departments in order to ensure that product is efficiently supplied to all non-clinical, clinical, and commercial sites.

• Serve as liaison between the IOPS site and all Tarrytown located departments.

• Coordinate the CMC regulatory activities required for submission of license applications, INDs, and other regulatory documents to government agencies.

• Lead special projects as assigned by supervisor/department management.
Education and Experience:

• Requires a BA/BS in any physical or Biological Science with 4-6 years industry related experience.

• 3+ years of related project management experience in a GMP environment with BA/BS; alternatively 1- year project management in industry with MA/MS or Ph.D. PMP certification or MBA a plus.

• Relevant experience may be considered in lieu of educational requirement.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.