Downstream Supervisor - 225402 at Medix™ in Hunt Valley, Maryland

Job Description:

The Fill/Finish Supervisor's role entails aiding in GMP Fill Finish manufacturing processes by applying extensive knowledge of theories, methods, and principles to address operational and routine tasks in aseptic production of biologic drug products for Phase I/II & commercial GMP manufacturing.

Responsibilities:

1. Supervise a team of manufacturing technicians.
2. Generate clinical and commercial materials annually to align with site objectives and comply with cGMPs and safety regulations.
3. Conduct floor training for staff as required.
4. Act as the primary point of contact during shifts to delegate tasks and manage emergencies.
5. Maintain qualifications for aseptic procedures.
6. Provide support and guidance to Manufacturing Technicians I, II, and III.
7. Ensure accuracy and currency of documentation such as batch records and SOPs.
8. Ensure safe, environmentally sound, and quality-compliant manufacturing operations.
9. Facilitate GMP and Safety training, emphasizing cross-training and continuous improvement.
10. Recommend equipment and supply acquisitions for production areas.
11. Lead by example in safety practices, including proper PPE usage.
12. Manage shift schedules and summarize progress at shift ends.
13. Lead and mentor staff, including conducting performance reviews, setting annual goals, and holding one-on-one meetings.
14. Communicate departmental results effectively through team discussions and documentation.
15. Maintain cGMP compliance in all documentation, reports, and records.
16. Initiate non-conformances and conduct investigations to ensure timely resolution.
17. Stay updated on current regulations, industry guidelines, and professional documentation.
18. Undertake additional duties as assigned.

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