Process Sciences Associate - Control Development& Lifecycle Management
We are looking to fill a Process Sciences Associate position as part of the Process Controls Development and Lifecycle Management Team with a Monday – Friday, 8 am-4:30 pm schedule. Regeneron has successfully commercialized numerous antibody therapies. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through process controls applied to our production processes. The Process Sciences Associate will collect and analyze data from across the business to develop robust Process Control programs. The Process Controls Development and Lifecycle Management Team employs a product ownership model, where Process Sciences Associates are responsible for supporting a program from process transfer through Regulatory filing and Commercialization. In this fast-paced environment with a strong pipeline, a Process Sciences Associate has an opportunity to work on countless aspects of the process and business.
As a Process Sciences Associate, a typical day might include the following:
- Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development team
- Analyzing development studies, enrichment studies, process validation and characterization studies, chemical stability studies, and/or historical manufacturing data to support development of process control programs.
- Evaluating product and process risks, and providing justification for implementing process controls or for making updates to existing process control programs.
- Assessing criticality of product attributes to support creation of product specifications.
- Drafting process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate.
- Coordinating with stakeholders to obtain additional data as needed to support creation, updates, and changes to process control programs.
- Presenting process control program structure, rationale, and methodologies during cross-functional meetings and to senior leadership when required.
- Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes.
This role might be for you if you:
- Understand antibody manufacturing processes.
- 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.
- Have a solid understanding of Microsoft Suite (Word, Excel, PowerPoint).
To be considered for the Process Sciences Associate I-IV (Process Sciences) position you must be willing and able to work Monday - Friday, 8 am to 4:30pm. You must have a BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred, as is a practical understanding of statistical methods. 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.