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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Visual Inspection Associate Program Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRensselaer, NY, USA$92.2k - $150.6k /yr

About the Job

Requirements

  • A bachelor's degree in a scientific or engineering discipline or related field, and 6 or more years of manufacturing experience, including prior supervisory experience or an equivalent combination of education and experience.
  • Experience in a current Good Manufacturing Practice fill/finish environment with exposure to visual inspection program elements.
  • Demonstrated leadership experience managing technical teams within a regulated manufacturing environment.

Responsibilities

  • Lead the Visual Inspection Technical Services team and Defect Creation Lab, building a culture of quality and continuous improvement.
  • Own the site's visual inspection program strategy, standards, and defect classification and acceptance criteria for liquid and lyophilized injectable products.
  • Ensure inspection processes and documentation meet USP <1790>, EU Annex 1, 21 CFR Part 211, and applicable ICH/PDA guidance.
  • Drive development of KNAPP/test sets and defect libraries used for operator and equipment qualification.
  • Monitor and trend program KPIs, such as defect detection and false reject rates, to guide data-driven continuous improvement.
  • Partner cross-functionally with Manufacturing, Quality Assurance, Regulatory, Process Development, and EHS on inspection processes, equipment, and product quality.
  • Evaluate emerging inspection technologies, including automated and artificial intelligence/machine learning-based detection, to drive program innovation.
  • Manage, coach, and develop team members while maintaining current Good Manufacturing Practice and Good Documentation Practice compliance across the program.

Desired Qualifications

  • Demonstrated ownership of visual inspection program elements and applicable regulatory requirements.
  • Experience evaluating or implementing automated and artificial intelligence/machine learning-based inspection technologies.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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