QC Chemist
1 week ago
We are a radiopharmaceutical company headquartered in the United States, operating in a state-of-the-art facility. Our company is dedicated to 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.
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 are possible.
Job SummaryWe are currently looking for experienced QC Chemists to join our team on our overnight shift, 9pm-8am, Sunday-Wednesday. As a QC Chemist, you will be responsible for performing QC stability testing, preparing and maintaining stability records and summaries.
Key Responsibilities- QC Stability Testing: Perform QC stability testing, prepare and maintain stability records and summaries.
- Method Development and Transfer: Develop, train, and transfer methods to and from QC and contract manufacturers as assigned.
- Analytical Procedure Validation: Modify and validate analytical procedures to meet QC needs.
- Experimental Protocol Design: Perform design and development of experimental protocols, SOPs, etc., consistent with cGMP/GLP.
- Quality Control Testing: Conduct all quality QC chemical tests for release of batches for patient use.
- Special Projects: Participate and lead special projects and department meetings via input, feedback, and execution of assigned tasks.
- Analytical Instrumentation: Adapt, maintain, and operate analytical instrumentation.
- Work Environment: Ensure the work environment is clean, safe and in compliance with safety and pharmaceutical regulations.
- Radiation Safety: Conduct radiation safety duties conforming to regulations.
- Supply Management: Report monthly on supplies for QC orders involving devices and reagents.
- Industrial Qualification and Validation: Contribute to industrial, R&D qualification and validation activities and support routine maintenance.
- Laboratory Investigations: Lead laboratory investigations and root-cause analyses.
- Chemical Reagent Preparation: Prepare chemical reagents for manufacturing and QC.
- Education: Bachelors Degree in Chemistry or Biochemistry required.
- Experience: Minimum of 3 years of applicable GMP laboratory experience required. Radiopharmaceutical experience preferred.
- Skills: 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).
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