Biopharma Manufacturing Lead
Biopharma Manufacturing Team Lead
My client is a pharma & biopharma company with multiple sites in Ireland. There’s a new role for a Biologics Manufacturing Team Lead to join a fast-paced and highly motivated team! In your role as the Manufacturing Team Lead, you will guide and support your new team by promoting a culture of compliance with aseptic best practice. This role is suited for an ambition person looking to further their career in biologics manufacturing to better the lives of the patients around the world.
- 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
- Provide daily reporting on the status of all operations and support activities
- Responsible for verification and updating of manufacturing control system transactions accurately and in a timely fashion
- Main 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
- Work closely with program management, Supply Chain, technical operations, Quality and Engineering groups to ensure effective execution of commercial and NPI manufacturing.
- Promote operations excellences culture and operations targets including OEE where applicable.
- 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
- Successfully review, amend, and implement changes to SOPs
- Develop your direct reports of manufacturing staff by securing appropriate training, assigning progressively challenging tasks, and managing mid-year and annual reviews
- Schedules resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.
- Provides required technical guidance and approval for manufacturing batch record
- Degree (Masters preferred) in Process, Bio, Chemical Engineering, or similar subject
- 5+ years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry.
- Experience of start-ups or NPI to biopharmaceutical/pharmaceutical facilities.
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
For further information on this Biopharma Manufacturing Team Lead role please contact Marchon Monroe on 086 044 9473/ firstname.lastname@example.org Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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