Biopharma Technical Lead — GMP Manufacturing & NPI

Life Science Consultants

Dublin

On-site

EUR 70,000 - 90,000

Full time

9 days ago

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Job summary

Life Science Consultants is assisting a biopharmaceutical company in Dublin in recruiting a Technical Lead to drive technical leadership across upstream and downstream manufacturing operations. The role focuses on supporting real-time troubleshooting and the successful introduction of new products, processes and technologies within a GMP environment.

The successful candidate will lead cross-functional teams on NPI, technology transfer, process improvements and site strategic initiatives, while

Qualifications

Bachelor's degree in Science, Engineering, Biotechnology, Chemical Engineering or related discipline.
Minimum 3 years' experience in Manufacturing Operations, Technical Support, Process or Equipment Engineering in Biopharma.
Strong knowledge of biological manufacturing processes and GMP environments.
Experience supporting media prep, buffer prep, sterile filtration and upstream/downstream processing.

Responsibilities

Provide technical leadership and subject matter expertise across upstream and downstream manufacturing operations.
Support manufacturing operations through real-time troubleshooting and resolution of process, equipment, automation and operational issues.
Lead and support introduction of new products, processes and technologies into the BDS manufacturing facility.
Provide manufacturing support during PPQ campaigns, validation activities and commercial manufacturing operations.
Lead and support cross-functional project teams delivering NPI, technology transfer, process improvement and site strategic initiatives.
Author, review and approve technical documentation including protocols, reports, process descriptions, SOPs, batch records, risk assessments, change controls and CAPAs.