Job Reference: JO-2012-65501_1607601926
As part of our clients start up phase, they are currently looking for an experienced Manufacturing Team Lead to join their existing highly skilled biologics fill-finish technician group. As the Manufacturing Team Lead, you will guide and support your new team across filling, lyophilization, equipment preparation, formulation, buffer preparation and processing activities in the biologics fill-finish facility to meet clearly stated operating objectives.
- Lead, motivate and develop the manufacturing team and provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls
- Promote a culture of contamination control and compliance with aseptic best practice
- Provide daily reporting on the status of all operations and support activities
- Take responsibility for verification and updating of manufacturing control system transactions accurately and in a timely fashion
- Act as a key point of technical contact for aseptic fill-finish activities including communicating departmental goals to biologics technicians and providing cost-effective quality compliant products in a safe, effective manner
- Liaise with program management, supply chain, technical operations quality, and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing
- Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits
- Ensure the execution of fill-finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives
Education and Technical Requirements:
- Degree qualified (masters/PHD preferred) in Process, Biopharmaceutical, Chemical Engineering, or other relevant discipline required
- A minimum of 5 years' experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry
- A minimum of 1-year team direct supervisory experience essential
- Detailed knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required for this role
- Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing
- Technical knowledge of Biologics/Aseptic Fill-Finish manufacturing process
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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