This non-supervisory role involves conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods. The Scientist will enhance the laboratory’s scientific proficiency and work ethic by offering extensive technical support and knowledge. Proficient in numerous common laboratory techniques, the Scientist provides valuable observations and insights into challenging projects and furnishes technical aid to the Verification Program by executing analytical tests and preparing comprehensive summary reports.
Key Responsibilities
- Conduct Verification projects (Dietary supplements/Dietary Ingredients) by performing individual analytical tests assigned by the Team Leader.
- Complete projects within designated timelines and priorities.
- Demonstrate a robust scientific approach to laboratory analysis.
- Utilize personal experience, academic training, and technical insights, including emerging sciences, to address complex technical issues within the laboratory.
- Compile project reports and respond to QA observations.
- Execute all testing and data analysis with precision, minimizing errors.
- Show a strong commitment to continuous learning and personal development.
- Propose and implement new approaches or processes to enhance laboratory operations.
- Influence project direction positively by aligning own work with the overall direction of laboratory projects.
- Assist with additional testing programs and laboratory maintenance tasks as required.
- Ensure compliance with Good Laboratory Practices (GLP) and safety systems in the laboratory.
- Maintain equipment calibration according to the schedule.
- Coordinate the procurement of chemicals, columns, glassware, etc., in advance, in coordination with lab operations and the purchase department, considering project deadlines.
- Adhere to US Pharmacopeia (USP) mission, policies, and procedures.
- Cultivate positive relationships with Quality Assurance (QA), Human Resources (HR), Purchase, Accounting, IT, and other departments.
- Participate actively in the preparation and planning for ISO-9001 & ISO-17025 certification/recertification, including taking an active role in internal QA and external audits and addressing audit issues promptly.
- Support Global Public Health (GPH), Reference Standard Laboratory (RSL), and other departmental teams as required for analytical testing, review, execution, and approval.
Qualifications
Minimum Requirements
- Master’s degree in pharmacy or Analytical chemistry.
- Minimum 1 to 3 years of relevant laboratory experience.
- Previous engagement in a high-volume pharmaceutical manufacturing QC laboratory or a contract pharmaceutical analytical testing laboratory, specifically pertaining to pharmaceutical dosage forms such as oral and liquid.
Additional Desired Preferences
- Proficiency in leading projects to completion with a high level of scientific expertise, including extensive knowledge of pharmaceutical testing requirements and test protocols encompassing compendial methods (USP, BP, EP, etc.).
- Strong preference for expertise in HPLC/GC operation with Empower software, as well as proficiency in ICP-OES, ICP-MS, LC-MS, and dissolution analysis with troubleshooting abilities.
- Adept in operating and troubleshooting other related analytical instrumentation (IR, KF, UV, etc).
- Exceptional communication and presentation skills, both verbal and written, with a preference for candidates experienced in the pharmaceutical industry.
- Familiarity with ICH guidelines and FDA regulations, along with experience in compendial procedures and compliance, is highly desired.
- Proficiency in Electronic Laboratory Notebook (ELN) is also preferred.
- Demonstrates a personal commitment to ensuring timely delivery of high-quality work and possesses the skills to anticipate, troubleshoot, and resolve technical challenges.
Supervisory Responsibilities
- None
Benefits
USP provides benefits to protect you and your family, including company-paid time off, comprehensive healthcare options, and retirement savings, ensuring personal and financial well-being.
