Summary:

Support and/or development and validation of methods to test new products manufactured at the site. Design testing of experimental, confirmation and registration lots, stabilities and new supplier certifications. Participate and/or develop the transfer of analytical technology to the commercial laboratories. 

Primary Functions:

1. Designs experiments to generate analytical methods suitable to support formulation development.
2. Develops and validates cleaning and analytical methods.
3. Performs compendial methods evaluation and prepares verification protocols and reports.
4. Evaluates the data generated by laboratory technologist and or laboratory analysts and trends.
5. Assures all the information regarding to the testing activities is documented on a timely manner in the corresponding laboratory logbooks and laboratory notebooks.
6. Prepares API, Raw Materials and Finished Product Specifications and Analytical Methods.
7. 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.
8. Performs or supports laboratory investigations as required.
9. Prepares progress reports and participate in Staff Meetings.
10.  Acts as a backup contact for the Analytical Development Manager.
11. Revises SOPs and keeps track of the weekly schedule.
12. Provides training to laboratory analyst and laboratory technologist as need.
13. Assures that files and records are maintained up to date.
14. Supports EHS program to assure compliance with safety policies.
15. Interprets results obtained during method development and troubleshoot tests as needed.
16. Ensures compliance with current pharmacopeia, FDA and ICH guidelines.
17. Updates specifications and test methods as needed.
18. Provides scientific coaching to laboratory personnel, such as training in specific analysis techniques, protocol instructions, and method development technics among others.
19. Prepares laboratory deviation reports.
20. Performs any other duties as assigned.

Education Requirement:

• 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.

Work Methodology:

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