Manufacturing Project Manager (Process and Regulatory Sciences)

Location
Rensselaer, NY, United States
Posted
Jul 17, 2019
Ref
17163BR
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Using Process Sciences, Regulatory Science and project management expertise, the Manufacturing Project Manager for Process and Regulatory Sciences serves as the manufacturing representative across functions and Regeneron locations, to manage Process and Regulatory Sciences activities within Manufacturing.

Level to be determined based on qualifications relevant to the role

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

• Supports Manufacturing in all CMC regulatory filing activities and works closely with Process Sciences Support to ensure all operational support is provided and received as required by production timelines

• Facilitate technical projects within manufacturing suites such as implementation of new process technologies

• Manage timelines in conjunction with CMC Program Management and Regulatory Sciences to ensure that regulatory submission strategies meets Manufacturing's needs

• Perform critical reviews of pre INDs, INDs, IMPDs, and BLAs to ensure a high quality regulatory submission and approval

• Prepares, distributes & presents project status reports to management

• Ensures all validation documentation is received by commercial manufacturing, executed and reviewed while maintaining the set timeline

• Coordination of reports and protocols such as PPQ, LIVCA, Hold time, buffer studies

• Point person for process validation sampling and timelines for reports and protocols

• Track and pull data for IPC program

• Partner with QC and process data monitoring to escalate issues and risks to manufacturing management

• Utilizes tools and mechanisms to ensure global alignment of manufacturing's processes, procedure and methods between all Regeneron and relevant partner sites

• Involved in daily operational activities

Knowledge and Skills:

• Upstream, Downstream and/or Formulation knowledge preferred

• Excellent writing and editing skills

• Strong attention to details

• Ability to effectively communicate issues and ideas with peers and with management

• Ability to build effective working relationships throughout the organization

• Ability to facilitate meetings with cross-functional teams

• Ability to operate independently within a tight deadline environment

• Is a high energy self-starter with a resilient, can-do attitude

• Ability to adapt to a quickly changing environment

Education and Experience:

• Requires BS/BA degree with a minimum of 5 years relevant experience

• Prior project management experience required. PMP strongly desired.

• Relevant experience may be substituted 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, disability status, protected veteran status, or any other characteristic protected by law.