Senior Technical Leader for Drug Product Development

4 days ago

Cork, Cork, Ireland beBeeDrugDevelopment Full time €95,000 - €145,000
Job Overview

BioMarin, a global biotechnology company, pursues innovative scientific solutions to translate genetic discoveries into groundbreaking medicines. The organization develops transformative treatments for patients with unmet medical needs, leveraging genetics and molecular biology expertise.

The Technical Operations group at BioMarin is responsible for creating drugs for clinical trials and scaling production for commercial markets. This team designs and maintains manufacturing processes, provides quality assurance and control, and procures goods and services to support manufacturing operations.

Key Responsibilities:
  • Technical expert supporting filling operations in a matrix team environment to achieve project objectives.
  • Develop process comparisons, risk assessments, manage technical and manufacturing risks, and identify mitigations.
  • Author technical reports to support process and product characterization.
  • Manage change control, deviations, and CAPAs through the quality management system.
  • Facilitate investigations, root cause analysis, and provide technical assessments for deviations.
  • Initiate and lead process improvement projects involving cross-functional teams.
Required Skills and Qualifications:
  • Strong understanding of MSAT or process development or technology transfer, with experience in large-scale processing of biologic drug products.
  • Possess a strong understanding of regulatory requirements and guidelines.
  • Proficient in technical writing and communication.
  • Excellent organizational, interpersonal, and problem-solving skills.
  • Capable of identifying and implementing continuous process improvements.
  • Ability to multi-task and manage tight timelines in a fast-paced environment.
  • Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project.
Benefits:

This role offers opportunities for career growth and professional development within a dynamic and innovative organization.

Others:

Please note that this job description may be subject to change based on business needs.

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