ATMP Process Controls Scientist

BioSpace; Town of East Greenbush (NY); Presencial; USD 67.000 - 129.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Process Controls and Validation Scientist to support manufacturing, quality and CMC regulatory activities for ATMP processes from tech transfer to post-commercial lifecycle management. Located in East Greenbush, NY, with 10% travel and a Monday–Friday 8:00–4:30 schedule, onsite collaboration across departments.

The role involves risk assessment, data analysis, protocol authoring, regulatory alignment, and audits support.

Formación

• Background in aseptic processing or drug substance/product development preferred.
• Experience with AAV, siRNA, peptides or synthetic chemistry processes preferred.
• Level determined by experience: Scientist or Sr. Scientist.

Responsabilidades

• Evaluate product and process risks during technology transfer and validation lifecycle.
• Analyze data from development through late-stage characterization and scale-up.
• Liaise with Manufacturing, Quality Control, QA and CMC regulatory.
• Author protocols, reports, and technical documents with data-driven conclusions.
• Ensure SOPs and validation plans align with regulatory expectations (ICH).
• Support audits/inspections and drafting CMC sections for regulatory submissions.
• Apply engineering principles to develop process controls and validation strategies.

Conocimientos

Aseptic processing

AAV experience

siRNA experience

Synthetic chemistry

Educación

Bachelor's degree in Chemistry/Biochemistry/Engineering or related field

Descripción del empleo

Regeneron is seeking a Process Controls and Validation Scientist to support manufacturing, quality and CMC regulatory activities for ATMP processes from tech transfer to post-commercial lifecycle management. Located in East Greenbush, NY, with 10% travel and a Monday–Friday 8:00–4:30 schedule, onsite collaboration across departments.

The role involves risk assessment, data analysis, protocol authoring, regulatory alignment, and audits support.