ATMP Process Controls & Validation Scientist - On-Site

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls and Validation Scientist to provide technical support to manufacturing, quality and CMC regulatory for processes from technology transfer to post-commercial lifecycle management.

This role focuses on ATMPs and collaborates with contract manufacturers. Based in East Greenbush, NY, the role requires collaboration with Manufacturing, Quality and Regulatory teams to develop and execute process controls and validation strategies, author

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.
• Scientist: BS/BA in Sciences with 2+ years proven experience
• Sr Scientist: BS/BA in Sciences with 5+ years proven experience

Responsibilities

• Evaluate product and process risks during technology transfer, design transfer, process control strategy development, LMP, process validation lifecycle and/or post-commercialization activities.
• Analyze information and data from development through late stage-characterization as well as at-scale manufacturing history.
• Liaise with Manufacturing, Quality Control, Quality Assurance and CMC to support process lifecycle management.
• Author protocols, reports, and other technical documents with conclusions based on process knowledge.
• Ensure SOPs, policies, validation plans align with regulatory expectations such as ICH guidelines.
• Provide support to audits/inspections and drafting CMC sections of regulatory submissions.

Skills

Process validation

Technology transfer

Regulatory liaison

Documentation

Education

BS/BA in Chemistry, Biochemistry, Engineering, or related field

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls and Validation Scientist to provide technical support to manufacturing, quality and CMC regulatory for processes from technology transfer to post-commercial lifecycle management.

This role focuses on ATMPs and collaborates with contract manufacturers. Based in East Greenbush, NY, the role requires collaboration with Manufacturing, Quality and Regulatory teams to develop and execute process controls and validation strategies, author