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QC Shift Manager
3 months ago
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. 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.
Responsibilities:
- Manage QC laboratory operations for Sunday-Wednesday factory shift (4 days x 10 hours/day).
- Oversee and perform QC testing, prepare and maintain stability records and summaries.
- Develop, train, and transfer methods to and from QC and contract manufacturers as assigned.
- Modify and validate analytical procedures to meet QC’s needs.
- Perform design and development of experimental protocols, SOP’s, etc., consistent with cGMP/GLP.
- Conduct all quality QC chemical tests for release of batches for patient use.
- Participate and lead special projects and department meetings via input, feedback, and execution of assigned tasks.
- Execute special projects on analytical and instrument problem solving.
- Perform timely radioactive and microbiological QC and record quality of product.
- Adapt, maintain, and operate analytical instrumentation.
- Ensure the work environment is clean, safe and in compliance with safety and pharmaceutical regulations.
- Conduct radiation safety duties conforming to regulations.
- Report monthly on supplies for QC orders involving devices and reagents.
- Contribute to industrial, R&D qualification and validation activities and support routine maintenance.
- Lead laboratory investigations and root-cause analyses.
- Prepare chemical reagents for manufacturing and QC.
Essential Education and Qualifications:
- At least 5 years GMP QC laboratory experience required, including people leadership experience.
- Excellent organizational skills required.
- Bachelor’s Degree in Chemistry or Biochemistry required.
- Experience using analytical techniques, such as High-Performance Liquid Chromatography (HPLC) and radio-Thin Layer Chromatography (rTLC).
- Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
- Ability to convey complex ideas in a simple manner to management and customers, exercise independent judgement during method development/transfer processes.
- Knowledge of analytical methods currently used for testing, release, and stability of sterile pharmaceutical products.
- Team oriented mindset and demonstrates ability to work easily with cross functional teams.
- Fluent in Microsoft Word and experienced in working with laboratory information management systems (LIMS).
