Process Sciences Associate- Validation

Rensselaer, NY, United States
Sep 05, 2020
Required Education
Associate Degree
Position Type
Full time
Regeneron is looking to fill a Process Sciences Associate position as part of the Process Validation Team. 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 through Process Validation. This position will be responsible for the validation package of Drug Substance and Formulated Drug Substance manufacturing processes. The Process Validation team employs a product ownership model, where Process Sciences Associates are responsible for supporting a program from process transfer through Process Validation and Regulatory filing. In this fast pace environment with a strong pipeline, Process Sciences Associates have an opportunity to work on countless aspects of the process and business.

As a Process Sciences Associate, a typical day might include the following:
• Work with a multi-functional team to support technology transfer and scale-up of processes from Regeneron's process development team
• Prepare and oversee execution of process validation protocols for all unit operations of the manufacturing process, such as cell culture, chromatography, and filtration unit operations.
• Statistically analyze large data sets and draft technical reports to support commercial filings.
• Present on technical topics during cross functional meetings.
• Provide technical support to Manufacturing during troubleshooting and continuous improvement opportunities.
• Serve as the functional area subject matter expert during regulatory inspections.

This role might be for you if:
• Enjoy working in a fast-paced environment and 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 and learning quickly.
• Ability to work in a team environment but can also take ownership of large technical reports and projects.
• Develop and drive scientific and/or business-related improvement ideas
• Understand antibody manufacturing processes.
• 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. You must have a BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry 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.