Process Controls & Validation Scientist

Regeneron Pharmaceuticals • Valley, AL

2d • $67,400 - $128,700 • Onsite

About The Position

The Process Controls and Validation Scientist provides technical support to manufacturing, quality, and CMC Regulatory (Chemistry, Manufacturing and Controls) for manufacturing processes, from technology or design transfer through post-commercial lifecycle management. The position focuses on a variety of Advanced Therapy Medicinal Products (ATMPs) and includes collaboration with contract manufacturing organizations. Process Sciences supports scientific, technical, engineering, and mathematical needs across laboratory and manufacturing settings. The position level will be determined based on experience and qualifications.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.
• Scientist level: BS/BA in Sciences and 2 or more years of proven experience.
• Senior Scientist level: BS/BA in Sciences and 5 or more years of proven experience.

Nice To Haves

• Background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation.
• Experience involving AAV (Adeno-Associated Virus), siRNA (small interfering RNA), peptides, and/or synthetic chemistry processes.

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 Regulatory to support management of the process lifecycle.
• Author protocols, reports, and other technical documents, drawing conclusions from available process and product knowledge.
• Ensure SOPs, policies, validation plans, and other internal documentation align with industry and regulatory expectations, such as ICH guidelines.
• Support audits and inspections and draft CMC sections of regulatory submissions as needed.
• Apply engineering principles to develop and execute process controls and validation strategies.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (including medical, dental, vision, life, and disability), paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level