Sr Process Controls & Validation Scientist

Regeneron is looking for a Sr. Process Controls & Validation Scientist for our Process Controls Development and Lifecycle Management Team. This is a non-lab-oriented position. 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. As a Sr. Process Controls & Validation Scientist, you will develop, lead, and maintain the process control program for each product. In this fast-paced environment with a strong pipeline, scientists in Process Sciences have an opportunity to work on various aspects of the process and business.

As a Sr. Process Controls & Validation Scientist, a typical day might include the following:

• Working with a multi-functional team to support technology transfer and scale-up of processes from Regenerons 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 or revising process control programs.
• Assessing criticality of product attributes.
• Drafting and revising process control documents and setting relevant limits using scientific rationale or statistical analysis, where appropriate.
• Contributing to and supporting Module 3: Quality (CMC information) submissions, reviews, and approvals.
• Communicating process control program structure, rationale, and methodologies during multi-functional meetings and to senior leadership when required.
• Supporting technology transfer activities to external manufacturing sites
• 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. You have in-depth knowledge of liquid chromatography; experience in analytical chemistry, pharmaceutical sciences and protein characterization using a variety of analytical tools for solution-based analyses.
• Have knowledge of regulatory and agency guidance and requirements for process control.
• Are familiar with ICH guidance, particularly Q8, Q9, Q11, and Q12
• Have the dedication to balance multiple projects and prioritize and implement them independently while excelling at keeping all impacted parties well advised.
• Enjoy working in a team environment but can also take ownership of complex 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 Sr. Process Controls & Validation Scientist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Life Sciences or related field; Biochemistry or Chemistry preferred and 5+ years of relevant experience; or equivalent combination of education & experience . A practical understanding of statistical methods and experience with regulatory guidance's and agencies is preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)