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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Process Compliance Specialist

Bioprocess & BiomanufacturingPosted on Nov 2
Full-timeLimerick, Ireland€37k - €88.4k /yr

About the Job

Requirements

  • A BS, BA, or BEng in Life Sciences or a related field, plus 2 years of relevant cGMP manufacturing, engineering, or scientific experience in a relevant industry, or an equivalent combination of education and experience.
  • For the Sr Specialist level, a BS, BA, or BEng in Life Sciences or a related field and 5 years of experience.
  • Demonstrate technical problem-solving capability.
  • Ability to prioritize and balance multiple tasks simultaneously.

Responsibilities

  • Provide technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor.
  • Coach and develop manufacturing personnel to strengthen technical knowledge, process understanding, and operational capability.
  • Support process improvements, CAPA implementation, and work system enhancements to drive performance and compliance.
  • Lead technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams.
  • Monitor, analyze, and present process trends, technical metrics, and operational data to support informed decision-making.
  • Conduct investigations into process variances and ensure adherence to cGMP, regulatory requirements, site procedures, and safety standards.
  • Oversee validation activities, equipment ownership responsibilities, and the scheduling of non-routine manufacturing operations.
  • Author, review, and approve controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives.
  • Collaborate effectively across functions to achieve shared business objectives.

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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