Process Controls & Validation Scientist

About the Role

We are seeking a Process Controls and Validation Scientist to provide technical support to manufacturing, quality, and CMC Regulatory (Chemistry, Manufacturing, and Controls) for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities. This role focuses on supporting a variety of Advanced Therapy Medicinal Products (ATMPs) and includes collaboration with contract manufacturing organizations.

Location and Schedule

Location: East Greenbush, NY
Shift: Monday - Friday, 8:00 AM - 4:30 PM
Travel: 10% domestic, occasionally international

Responsibilities

• Evaluate product and process risks during technology transfer, design transfer, process control strategy development, lifecycle management, and post-commercialization activities.
• Analyze information and data from development through late-stage characterization and at-scale manufacturing history.
• Liaise with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory to support process lifecycle management.
• Author protocols, reports, and other technical documents with conclusions based on all available process and product knowledge.
• Ensure alignment of SOPs, policies, validation plans, and internal documentation with industry and regulatory expectations (e.g., ICH guidelines).
• Provide support for audits/inspections and drafting of CMC sections of regulatory submissions as needed.
• Apply engineering principles to develop and execute process controls and validation strategies.

Requirements

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

Preferred Qualifications

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

Pay

Salary Range (annually): $67,400.00 - $128,700.00