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Manufacturing Lead

2 months ago

springfield, United States Evergreen Theragnostics Full time

About Us


Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, providing 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. The company expects rapid growth in the next few years.


Evergreen is 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 Lead for our Overnight Shift, Sunday-Wednesday (9pm-8am).


Overview

The Manufacturing 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 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.


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.


Education and Qualifications

  • 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.