Senior Manufacturing Biotech Associate

Senior Manufacturing BioTech Associate - a site based position working 24/7 shifts.

• Execute automated recipes using paperless technology to manufacture drug substance.
• Prepare, operate, and monitor equipment; use business systems; perform cleaning, validation, and in process testing.
• Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.
• Conduct all work activities with strict adherence to safety and compliance culture on site.
• Set up single use equipment between runs and carry out the production process in accordance with world class GMP and EHS standards.
• Optimize and improve processing activities through the use of standard work and lean processing techniques.
• Focus on delivery to the patient by living the Dunboyne culture - commitment to safety, right first time execution, and engagement and development of self and peers.

• Level7 qualification in a science or engineering discipline desired.
• Level6 with a minimum of 3+ years' experience in a GMP manufacturing environment deemed equivalent.
• Competent in troubleshooting and practical problem solving capabilities.
• Ability to work independently and within a cross functional team.
• Familiarity with contamination control and batch release requirements.
• Understanding of upstream and downstream unit operations for mAb manufacturing.
• Experience with Emerson DeltaV, PASX, and automation in a manufacturing process.
• Experience with various single use techniques and end to end single use facility operations.
• Strong knowledge of biopharmaceutical manufacturing, GMP, regulatory compliance, shift work, teamwork, and independent work.

Location: Dunboyne site - first biologics drug substance single use commercialization facility.