ATMP Process Controls & Validation Scientist

Regeneron Pharmaceuticals, Inc (USA)

New York (NY)

On-site

USD 90,000 - 150,000

Full time

4 days ago

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Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Process Controls and Validation Scientist to provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer to post-commercialization activities. The role focuses on ATMPs and involves collaboration with contract manufacturing organizations; location is East Greenbush, NY.

The role requires a Bachelor's degree in Chemistry, Biochemistry, Engineering, or related field, with 2+ years for

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related field.
Scientist requires 2+ years proven experience in the sciences.
Sr Scientist requires 5+ years proven experience in the sciences.
Background in aseptic processing or biopharmaceutical/combination product validation preferred.
Experience with AAV, siRNA, peptides or synthetic chemistry processes preferred.

Responsibilities

Evaluate product and process risks during technology transfer, design transfer, process control strategy development, LMP, and validation lifecycle.
Support audits/inspections and drafting of CMC sections of regulatory submission.
Author protocols, reports, and other technical documents with conclusions based on available process and product knowledge.
Collaborate with Manufacturing, Quality Control, Quality Assurance and CMC regulatory to manage the process lifecycle.