Scientist, Clinical Research Expert

2 weeks ago

Summit, New Jersey, United States Progressive Recruitment Full time
Job Title: Scientist, Clinical Research

We are seeking a highly skilled and experienced Scientist, Clinical Research to join our team at Progressive Recruitment. As a key member of our research team, you will be responsible for providing scientific leadership and hands-on technical expertise in trouble shooting and conducting analytical research and development of pharmaceutical materials.

Key Responsibilities:
  • Provide scientific leadership and guidance to laboratory staff in method development and validation for the analysis of starting materials, intermediates, and finished products in accordance with cGMP regulations, established protocols, and all applicable SOPs.
  • Conduct hands-on scientific research to understand the fundamentals of the methods, materials, and the products.
  • Perform hands-on trouble shooting of methods and investigation of products.
  • Prepare scientific publications for submission to peer-reviewed journals.
  • Ensure that all facilities, equipment, and daily activities are and remain in compliance with cGMP regulations, relevant regulatory guidelines, and appropriate SOPs.
  • Develop, optimize, and validate analytical methods.
  • Investigate and trouble shoot any technical issues with methods, materials, and products.
  • Qualify/transfer analytical methodology to quality control or contract laboratories.
  • Support drug product development and characterization of drug substances and impurities.
  • Review analytical data.
  • Assist analytical project team leader to meet CMCDT deliverables.
Requirements:
  • Working knowledge of cGMP, FDA, and ICH guidelines.
  • Familiar with USP and other compendia.
  • A comprehensive knowledge in chemistry and pharmaceutical sciences.
  • Strong problem-solving and troubleshooting skills.
  • Extensive hands-on experience and knowledge with LC-MS, HPLC, and Dissolution testing.
  • Strong verbal/written communication and interpersonal skills as a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required.
  • Ability to work independently with minimal supervision.
  • Demonstrated track record of scientific publications.
Specific Requirements:
  • Must have knowledge and hands-on experience in HPLC method development and validation and impurity identification using LC-MS.
  • Comprehensive knowledge in developing dissolution methods for various solid oral dosage forms is a plus.
  • Medical background.
  • At least 5 years' experience focused on Hematology/Oncology.
  • Must be able to function independently in data cleaning (data analysis experience not needed).

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