Regeneron

Process Controls & Validation Scientist

RENSSELAER Full time

We are seeking a highly motivated Process Controls and Validation Scientist to join our team and play a pivotal role in supporting manufacturing, quality, and CMC Regulatory (Chemistry, Manufacturing, and Controls) activities. This position is specifically focused on Advanced Therapy Medicinal Products (ATMPs) and involves collaborating closely with contract manufacturing organizations (CMOs) to ensure successful technology transfer, process validation, and lifecycle management of cutting-edge therapies.

In this role, your typical day might include:

  • Provide hands-on technical support for activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle, and post-commercialization activities.
  • Assess product and process risks at various stages of the product lifecycle, including development, transfer, and commercialization.
  • Analyze data from early development, late-stage characterization, and at-scale manufacturing to ensure robust and reliable processes.
  • Work closely with departments such as Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory to manage the process lifecycle effectively.
  • Author protocols, technical reports, and other key documents that summarize findings and recommendations based on comprehensive process and product knowledge.
  • Ensure alignment of internal documentation (SOPs, validation plans, policies) with industry standards and regulatory guidelines, including ICH requirements.
  • Apply engineering concepts to develop and execute process control and validation strategies that meet industry and regulatory expectations.

This role might be for you if:

  • You have a strong background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation.
  • You have experience with process control development, particularly involving AAV (Adeno-Associated Virus), siRNA (small interfering RNA), and/or synthetic chemistry processes.
  • You excel at analyzing data using statistical methods, engineering principles, and other techniques to gain insights into manufacturing process performance and control.
  • You thrive in a fast-paced environment and enjoy tackling complex technical challenges.
  • You’re comfortable with occasional travel (10-15% annually) to support project needs.

To be considered for this role, you must have a bachelor’s degree in life sciences or engineering and at least 5+ years of relevant experience in process controls, validation, or a related area. A higher degree is preferred.

The level of this position will be determined based on your experience and qualifications.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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)

$67,400.00 - $110,000.00