SUMMARY OF THE POSITION:

This is a hands-on non-supervisory position responsible for successful implementation and completion of all activities pertaining to a portfolio of Early Procedure Evaluation (EPE) evaluation. The incumbent is responsible for evaluating the sponsor’s or alternative source test procedures in USP laboratory to identify and resolve any issues related to the functionality of the test method before publication in the Pharmaceutical Forum (PF). This can apply to, but not limited to, new reference standards (RS), new uses of RS, new drug substance monographs, modernization/revision proposals and dosage form monograph procedures for Chemical Medicines, Excipients, Dietary Supplements, Biologics and Food Ingredients.

ROLES AND RESPONSIBILITIES:

• Cooperate with RSS to set up related workflow and SOP
• Evaluate the lab request form and request additional information as necessary, accept or reject the lab request
• Execute the requested procedures, as per the Lab Request Form to appropriately evaluate the functionality of the method
• Generate a Final Test Report and review and approve. If the EPE is for new uses of an existing RS then it should also be sent to QA for review and approval.

Required Skills Required Experience

MINIMUM REQUIREMENTS 

EDUCATION:BS OR HIGHER DEGREE IN CHEMISTRY OR RELEVANT FIELD.

SCIENTIST III: MINIMUM 5 YEARS OF LAB RELATED EXPERIENCE FOR MS, OR 7 YEARS FOR BS, KNOWLEDGE, SKILLS AND ABILITIES: 

• Must have demonstrable expertise in analytical chemistry and familiar with instrumentation such as HPLC, GC, IC, AA, ICP, CHN, IR, UV/Vis, MS, TLC, Dissolution, Titration and wet chemistry.
• Hands on experience and solid knowledge of general analytical methodologies
• Must be output driven and able to work in a well-organized environment and respond to shifting priorities.
• Excellent technical writing, understanding and communication skills in English
• Must have ISO 17025 or GMP/GLP pharmaceutical analytical lab working experience.
• Operates collaboratively and team player in a highly technical environment.
• Previous analytical technical training experience is preferred
• Familiar with business and scientific computer systems and instrument software applications
• With capability to translate or explain data in scientific manor
• Previous R&D of API in-process control or drug product development experience is preferred.
• Solid knowledge and deep understanding of analytical method development and validation process.

SUPERVISORY RESPONSIBILITIES: 

None