Senior Biologic Product Specialist

4 days ago

Cork, Cork, Ireland beBeeBiologist Full time €90,000 - €110,000
Job Opportunity:

The Senior Engineer, Drug Product role involves supporting filling operations and collaborating with cross-functional teams to achieve project objectives.

Key responsibilities include:

  • Technical SME for drug product (DP) supporting filling operations
  • Developing process comparisons, risk assessments, managing DP technical and manufacturing risks, and identifying appropriate mitigations
  • Authoring technical reports to support DP process and product characterization
  • Managing change control, deviations, and CAPAs through the quality management system until closure
  • Facilitating investigations, root cause analysis for deviation resolution, data gathering/analysis, and providing technical assessments for deviations
  • Initiating and leading process improvement projects, involving cross-functional teams
  • Supporting the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery
  • Assisting with PPQ campaign readiness and providing in-person, on-the-floor execution support for technical runs and PPQ campaigns as required

Requirements include:

  • Strong understanding and hands-on experience in MSAT or process development or technology transfer, background in large-scale processing of biologic drug products
  • Possessing a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products
  • Having a solid understanding of regulatory requirements and guidelines
  • Being proficient in technical writing
  • Demonstrating ability to build strong partnerships and work effectively with diverse team members in a dynamic environment
  • Excellent organizational, interpersonal communication, and problem-solving skills
  • Capable of identifying, communicating, and implementing continuous process improvements
  • Ability to multi-task and manage tight timelines in a fast-paced environment
  • Able to work on the manufacturing floor for extended periods during the execution of technical protocols

This is an exciting opportunity for a skilled engineer to make a meaningful impact in the field of biologic drug products.

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