ATMP Process Controls & Validation Scientist

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY is seeking a Process Controls and Validation Scientist to bolster manufacturing, quality, and CMC regulatory activities for ATMP processes across technology transfer to post-commercial lifecycle management.

This role collaborates with contract manufacturers to ensure robust process control strategies. The position requires a Bachelor's in a relevant field and 2+ to 5+ years of experience, with responsibilities spanning risk assessment, data

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 other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle
• Author protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
• Ensure alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
• Provide support to audits/inspections and drafting of CMC sections of regulatory submission as needed
• Apply engineering principles to the development and execution of process controls and validation strategies

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related field

BS/BA in Sciences with 2+ years proven experience

BS/BA in Sciences with 5+ years proven experience

Job description

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY is seeking a Process Controls and Validation Scientist to bolster manufacturing, quality, and CMC regulatory activities for ATMP processes across technology transfer to post-commercial lifecycle management.

This role collaborates with contract manufacturers to ensure robust process control strategies. The position requires a Bachelor's in a relevant field and 2+ to 5+ years of experience, with responsibilities spanning risk assessment, data