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Regeneron is currently looking for a Process Controls and Validation Scientist. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Controls and Validation Scientist provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

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

• Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.

• Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.

• Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history.

• Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.

• Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.

• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.

• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.

• Applies principles of biology, chemistry and other scientific fields to the development and execution of validation strategies.

• Analyzes data using a combination of statistics, scientific principles, and other techniques to gain insights into manufacturing process performance and control.

• Works effectively and efficiently in a team-oriented environment.

• Provides support for laboratory studies and/or studies performed at manufacturing scale.

This role might be for you if you:

• 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 Process Controls & Validation Scientist you must have a BS/BA in Life Sciences. For various levels you must have the following:

• Associate Process Controls & Validation Scientist r: 0-2 years of relevant experience

• Process Controls & Validation Scientist: 2+ years of relevant experience

• Sr. Process Controls & Validation Scientist: 5+ years of relevant experience

Experience in aseptic processing, drug substance development, drug product development or biopharmaceutical/ combination production validation is preferred. Level is determined based on qualifications relevant to the role.

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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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$58,480.40 - $124,300.00