Manufacturing Shift Manager - Biologics
- Westport, Co Mayo
- Permanent
- Full-time
- Act as key point of technical contact for aseptic fill finish activities.
- Supervision and execution of compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives
- You will lead, coach & mentor your manufacturing team, across a 12-hour rotating shift, to maximize the effectiveness through clear and effective communication of task details and goals to their team members, to allow the biologics technicians to work effectively
- As part of this diverse and inclusive team, you will conduct on the floor promotion of a culture of contamination control and compliance with aseptic best practice.
- Communicate the departmental goals, to provide cost effective quality compliant products in a safe, effective manner
- We believe in collaboration so in this role, you will 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
- Resolve operations/project issues by working with team members, project customers, and others as appropriate.
- Responsible for driving operations excellences and Key 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
- Minimum of 3 year's experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.
- A minimum of 1 year team direct supervisory experience in a team environment
- 3rd level qualification in a Science, Engineering or related scientific field, advanced degree is preferred
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
- Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
- Has a technical background in pharmaceutical, biologics, or similar industries
- Flexibility with working 12-hour shift, rotating between days and nights on a monthly rotation
- Possess a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions