QC Laboratory Manager
2 weeks ago
We are a radiopharmaceutical company headquartered in New Jersey, operating in a state-of-the-art facility. Our team provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and diagnostics. We also conduct cutting-edge cancer research, developing proprietary medicines.
We are a small, collaborative team where everyone supports each other in various activities. We are looking for motivated team members who are excited to help build the company and take on new challenges. Partial equity-based compensation packages are possible.
Job Responsibilities- Manage QC laboratory operations for the Sunday-Wednesday overnight factory shift.
- Oversee and perform QC testing, prepare stability records, and summaries.
- Develop, train, and transfer methods to and from QC and contract manufacturers.
- Modify and validate analytical procedures to meet QC needs.
- Design and develop experimental protocols, SOPs, and conduct quality chemical tests for batch release.
- Participate in special projects and department meetings, executing assigned tasks.
- Execute analytical and instrument problem-solving projects.
- Perform timely radioactive and microbiological QC and record product quality.
- Adapt, maintain, and operate analytical instrumentation.
- Ensure a clean, safe work environment and compliance with safety and pharmaceutical regulations.
- Conduct radiation safety duties and report monthly on supplies for QC orders.
- Contribute to industrial, R&D qualification, and validation activities.
- At least 5 years of GMP QC laboratory experience, including people leadership experience.
- Excellent organizational skills and a Bachelor's Degree in Chemistry or Biochemistry.
- Experience with analytical techniques, such as HPLC and rTLC.
- Excellent communication, organizational, and problem-solving skills.
- Ability to convey complex ideas and exercise independent judgment.
- Knowledge of analytical methods for testing, release, and stability of sterile pharmaceutical products.
- Team-oriented mindset and experience working with cross-functional teams.
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