Tulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can support product development, analytical testing, product registration, and commercial manufacturing and packaging of high-quality drug products. We are committed to commercializing products through strategic partnerships with the US and other major markets.
Role Description
You will be responsible for conducting extractable and leachable testing of packaging materials for liquid oral dosage forms, including but not limited to strategy design, method development, qualification, validation, and testing. You will also be responsible for developing other analytical methods for drug substances, raw materials, and drug products.
Qualifications
·· Ph.D. degree or Master’s degree in Chemistry or related fields
· At least 3 years (Ph.D.) or 5 years (Master’s degree) of extractable and leachable experience in the Pharmaceutical industry.
· Must have extractable and leachable testing skills and experience
· Extensive experiences in operating and data interpretation of LC/MS/MS and
· Solid knowledge in Chemistry
· Ability to development analytical methods independently
· Strong problem-solving capability
· Deep understanding of Pharmaceutical and cGMP regulation
· Excellent work attitude/ethics
· Good time management skill, flexibility, and multi-tasking abilities
· Ability to follow Good Documentation Practice for notebook recording, protocol design and report writing
· Must be a good team player
· Excellent oral and written communication
· Proficient in Microsoft Office
Employment type
Full-time
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