Biologics Manufacturing Specialist

6 hours ago

Sligo, Sligo, Ireland beBeeProcessScientist Full time €55,000 - €85,000

Key Role: Process Scientist

We are seeking a highly skilled and experienced professional to lead our biologics manufacturing operations. As a Process Scientist, you will play a vital role in the development and evolution of single-use materials used in biologics manufacturing processes.

Key Responsibilities:
  • Work collaboratively with cross-functional teams and global science and quality teams on the design, qualification, and validation of single-use assemblies for biologics manufacturing.
  • Lead risk assessments for product path introduction or modification, including required change management activities, and develop technical documents such as protocols, procedures, and manufacturing batch records.
  • Engage with manufacturers and vendors to advance best practices and validation packages, and serve as technical lead for single-use complaints.
  • Support the development of manufacturing processes for new products, including specification development and review.
  • Provide operational technical support for process-related issue resolution, design experiments to investigate new processes or failure modes, and assist in investigations related to single-use process deviations.
  • Monitor and analyze process data during manufacturing to optimize performance.
  • Supervise and train operations personnel for single-use processes, ensuring adherence to EHS&E standards, procedures, and policies.
Required Skills and Qualifications:

Degree in science, engineering, or relevant technical field

At least 2+ years of direct experience using single-use materials in GMP environments

Experience in the design, onboarding, and qualification of single-use assemblies for biologics manufacturing

Proven ability to collaborate with vendors and global stakeholders

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