Process Sciences Associate - Process Control Compliance

We are currently looking to fill a Process Sciences Associate position as part of the IPC (In-Process Controls) Development Compliance team with a 1st shift, 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 controls applied to our production processes. This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory Departments through compliance activities and documentation related to implementation and maintenance of in-process control programs for manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, Process Sciences Associates have an opportunity to work on countless aspects of the process and business.

As a compliance focused Process Sciences Associate, a typical day might include the following:

• Compiling and organizing information, preparing documentation, evaluating risks, and providing justifications for implementing or updating IPC Programs throughout the Change Control Process.
• Completing and/or reviewing IPC documentation associated with batch manufacture.
• 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 updates and changes to the IPC programs.
• Presenting on compliance topics to senior leadership and during cross functional meetings.
• Participating in brainstorming sessions where we look for ways to improve our development and compliance processes.
• Assisting in troubleshooting and providing compliance support to the IPC Development Team as needed.

This role might be for you if you:

• Enjoy working in a fast-paced environment.
• 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 Process Sciences Associate position you must be willing and able to work Monday-Friday, 8am-4:30pm. 

For various levels you must have the following: 
Process Sciences Associate I: BS/BA or MS in life sciences/engineering or related field.
Process Sciences Associate II: BS/BA or MS in life sciences/engineering or related field and 2+ years of relevant experience
Process Sciences Associate III: BS/BA or MS in life sciences/engineering or related field and 5+ years or relevant experience
Process Sciences Associate IV: BS/BA or MS in life sciences/engineering or related field and 8+ years or relevant experience
Experience with statistics and analytical methods (HPLC, ELISA, qPCR, SDS-Page) is preferred. The level is determined based on qualifications relevant to the role. 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 eligible 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 parental 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.