Manufacturing Operations Lead
22 hours ago
About Evergreen Theragnostics
We are a radiopharmaceutical company headquartered in the United States, operating in a state-of-the-art facility. Our company provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We also operate our own cutting-edge cancer research laboratories, developing proprietary, radiotherapeutic medicines. Our company expects rapid growth in the next few years.
We are a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
We are currently seeking a Manufacturing Operations Lead for our Overnight Shift, Sunday-Wednesday (9pm-8am).
Job Overview
The Manufacturing Operations Lead supports the Head of Facility Operations and Manufacturing Manager in overseeing sterile manufacturing in a 21 CFR Part 211 cGMP cleanroom environment. Specifically, the Manufacturing Operations Lead has the responsibility of leading teams of technicians and other manufacturing personnel either by project or by shift for the completion of projects on a routine basis. A high level of technical proficiency, combined with supervisory or management experience is preferred.
Key Responsibilities
- Ensure proper aseptic techniques are followed during the manufacturing process.
- Assist in the supervision of manufacturing personnel during cleaning, preparation, and manufacture of radiopharmaceuticals for timely release.
- Gather, prepare, and organize materials needed for manufacturing.
- Assist in the supervision and training of team members to operate and maintain chemistry modules and automated dispensing systems.
- Manage the manufacturing investigations and technology transfers with the Project Management team.
- Collaborate with the Quality Assurance team to create, review, and enforce protocols and assist with quality investigations.
- For various projects and assignments, manage the production schedule and communicate with team members to set their schedules, adjust to changes, and ensure coverage for all runs.
- Ensure that all batch records are completed according to GDP (Good Documentation Practice) standards.
- Observe radiation safety principles during preparation and production.
- Perform coaching and mentoring to manufacturing team.
- Develop training content and lead training for the team, working closely with the Manufacturing Manager, Head of Facility Operations, and Radiopharmacist, Manufacturing Lead.
Requirements
- Bachelor's Degree required, except in cases of exceptional experience. Higher level degree desirable, PharmD desirable.
- Proven experience with aseptic gowning and operating in a cleanroom environment.
- Experience in working with Laboratory Information Management Systems (LIMS).
- Prior experience in a lead or supervisory role on a production team required.
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