Scientist, Clinical Research

Scientist, Clinical Research

Provide scientific leadership and hands on technical expertise in trouble shooting and conducting analytical research and development of pharmaceutical materials under minimal guidance and oversight from his/her supervisor.

Responsibilities will include, but are not limited to, the following:

• 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
• Require significant hands-on involvement in the laboratory
• Prepare documents and reports
• Author and co-author manuscripts for publication Skills/Knowledge

Required:

• 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)

All your information will be kept confidential according to EEO guidelines.

If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!