Manager or Sr. Manager of Analytical Research and Development

4 weeks ago

Cranbury, United States Tulex Pharmaceuticals Inc. Full time

Company Description

Contact: fliu@tulexpharm.com

Tulex Pharmaceuticals is a technology-driven specialty pharmaceuticals company based in Cranbury, NJ. The company was established in the fall of 2014 and is led by a team of highly experienced and proven scientists. Tulex focuses on developing and marketing innovative drug products to serve needy patients. The company has expanded from a Research and development entity to a fully functional cGMP facility capable of product development, analytical testing, product registration, and commercial manufacturing and packaging of high-quality drug products. Tulex plans to commercialize products via strategic partnerships with the U.S. and other major markets.


Role Description

You will lead and manage an analytical research and development team. The primary responsibilities include but are not limited to managing the activities of analytical method development, phase-appropriate method validation, characterization of raw material, drug substance, and drug product, formulation development support, analytical data interpretation, troubleshooting and investigation, and employee training.  


Qualifications

· Ph.D. degree or Master’s degree in chemistry or related fields. Ph.D. is preferred.

·       At least 2 years of managing analytical research and development team experience in the pharmaceutical industry. 

·      At least 5 years of method development experience in small molecule drug substances and products.

·      Extensive experience in operating and data interpretation of HPLC, UPLC, Dissolution, and GC. Experience in LC/MS/MS and GC/MS is a plus.

·      Solid knowledge of Chemistry

·      Expertise in analytical method development by QBD

·      Analytical LC/MS/MS documents authoring skills

· Must have good time managing skills, self-directing, and adaptability to a fast-paced working environment.

·      Quick thinking and strong problem-solving capabilities

·      Deep understanding of Pharmaceutical and cGMP regulation

·      Excellent work attitude/ethics

·      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

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