Laboratory Scientist-Analytical Development
- Caguas, PR
- Permanente
- Tiempo completo
- 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
- Flexible to work flexible shifts including weekends