Job Title: Shift Manufacturing Supervisor
The role of the Shift Manufacturing Supervisor is a critical part of the Operations Leadership Team, responsible for leading a team of Manufacturing Process Technicians and Senior Associates on a 4-cycle shift rotation involved in formulation and aseptic filling of biopharmaceuticals (Syringes/Vials) in compliance with Good Manufacturing Practices. The supervisor ensures adherence to the production schedule by actively managing operations during the shift in collaboration with support functions (Maintenance, Engineering, Quality, Planning). They maintain a strong culture of Safety and Quality within their team and in the manufacturing area in general.
Key Responsibilities:
- Model Amgen's values and leadership attributes, ensuring that all activities completed within the manufacturing clean rooms are executed to the highest standards of quality, protecting the safety of the manufacturing team while delivering on our manufacturing schedule commitments.
- Effectively manage a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety, and other regulatory standards.
- Facilitate daily scheduling and work centre team meetings, ensuring that all groups are aligned on all critical activities to meet the manufacturing plan.
- Maintain up-to-date production finite schedules reflecting the status of the manufacturing process.
- Lead problem-solving on their shift, working with cross-functional support groups to identify and resolve process-related issues minimizing impact on the manufacturing schedule.
- Act as an Aseptic Coach, continuously observing and advising on aseptic practices in the manufacturing clean rooms.
- Ensure their team compiles, maintains, and reviews necessary reports, documentation batch records/Electronic Batch Records (EBRs), using relevant software systems and standard operating procedures.
- Collaborate and liaise with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services, and Human Resources organizations to achieve objectives of the Manufacturing Department.
- Be responsible for people management within their reporting line, in line with the company's policy and standards, ensuring active engagement in the development of their team and ongoing performance assessments and management via the Maximizing Amgen's Performance (MAP) process, ensuring their team have a clear understanding and are accountable for the performance levels expected of them.
- Proactively identify training needs for their manufacturing shift and direct reports, facilitating completion of training as per Amgen's learning management system and production requirements.
- Implement lean practices and assist, plan, and implement continuous improvement ideas and opportunities using lean principles.
- Contribute and assist with corporate, FDA, HPRA, and other regulatory bodies during company audits.
Basic Qualifications & Relevant Experience:
- Bachelor's degree in Engineering or Science or related discipline
- Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
- 5+ years' experience in Syringe/Vial aseptic manufacturing operations or have relevant GMP manufacturing experience and a demonstrated capacity to learn quickly and adapt to new technology
- Previous experience in managing and leading teams
Preferred:
- Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.
- Strong people management experience including performance management, coaching, mentoring, and development of the manufacturing team.
- Strong ability to lead, challenge, and positively influence in an interactive team environment
- Strong computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS), and personnel performance tracking (MAP's) etc.