Associate Manager Process Sciences- IPC Development
Regeneron is looking to fill an Associate Manager- Process Sciences position as part of the IPC (In-Process Controls) Development and Lifecycle Management Team with a Monday - Friday, 8am-4:30pm schedule. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through in process controls applied to our production processes. This position will be responsible for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. This position will also be responsible for managing Process Sciences Associates and Scientists who develop and maintain the IPC program for each product. In this fast-paced environment with a strong pipeline, Associate Managers in Process Sciences have an opportunity to work on countless aspects of the process and business.
As an Associate Manager in Process Sciences, a typical day might include the following:
• Compiling and organizing information, preparing documentation, evaluating risks, and providing justifications for implementing or updating IPC Programs
• Completing and/or reviewing IPC documentation associated with batch manufacture or for regulatory filings
• Reviewing technical documents and reports for content, formatting, and data consistency prior to document approval
• Coordinating with stakeholders to obtain data and statistically analyzing the data received in order to write technical reports to support creation, updates, and changes to the IPC programs
• Presenting on IPC program and the methodologies used to establish the action limits to senior leadership and during cross functional meetings
• Participating in brainstorming sessions where we look for ways to improve our IPC development and lifecycle management processes
This role might be for you if you:
• Enjoy working in a fast-paced environment
• Managing a team of individuals focused on developing and maintaining GMP process controls
• You are detail oriented, quality driven and well organized
• You have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised
• Can take on new and sometimes ambiguous challenges, learning quickly
• You enjoy working in a team environment but can also take ownership of multi-faceted projects and technical reports
• Can develop and drive scientific and/or business-related improvement ideas
• Understand antibody manufacturing processes
• Have a solid understanding of Microsoft Suite (Word, Excel, Powerpoint)
To be considered for the Associate Manager (Process Sciences) position you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred, with 6+ years of relevant industry experience. Previous leadership experience required. Or an equivalent combination of education and experience. Practical understanding of statistical methods preferred. 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.