Laboratory Scientist - Product Development

• Develops and validates cleaning and analytical methods.
• Performs compendial methods evaluation and prepares verification protocols and reports.
• Evaluates the data generated by laboratory technologist and or laboratory analysts and trends.
• Assures all the information regarding to the testing activities is documented on a timely manner in the corresponding laboratory logbooks and laboratory notebooks.
• Prepares API, Raw Materials and Finished Product Specifications and Analytical Methods.
• Evaluates Technical Transfer Packages and prepares Analytical Method Transfer Protocols and Reports. Evaluates raw data, perform troubleshooting of analytical methods and oversee laboratory work performed by laboratory analyst and technologists.
• Performs or supports laboratory investigations as required.
• Prepares progress reports and participate in Staff Meetings.
• Acts as a backup contact for the Analytical Development Manager.
• Revises SOPs and keeps track of the weekly schedule.
• Provides training to laboratory analyst and laboratory technologist as need.
• Assures that files and records are maintained up to date.
• Supports EHS program to assure compliance with safety policies.
• Interprets results obtained during method development and troubleshoot tests as needed.
• Ensures compliance with current pharmacopeia, FDA and ICH guidelines.
• Updates specifications and test methods as needed.
• Provides scientific coaching to laboratory personnel, such as training in specific analysis techniques, protocol instructions, and method development technics among others.
• Prepares laboratory deviation reports.
• Performs any other duties as assigned.

• Bachelor's Degree in Chemistry (Analytical, Organic or Pharmaceutical).
• Eight (8) years of related experience in analytical laboratory.

• Experience in method validation (preparation of protocols and reports), analytical technology transfer and cleaning validation are required for pharmaceutical small molecules.
• Experience in a cGMP regulated analytical laboratory.
• Knowledge in FDA, ICH and USP requirements.
• Hands on experience in analytical method validations.
• Proficient in the use of LIMS system.
• Exercise attention to detail.
• Strong technical writing skills.
• Capable to read and interpret correctly scientific and technical literature.
• Excellent communication skills in English and Spanish.

• 100% On-site
• 6 months (1st Contract)
• Administrative Shift (available to work flexible shifts, including weekends and overtime, as required).
• Temporary Contract

CIS International LLC