About This Role
This laboratory position involves developing and validating analytical methodologies to support research projects, focusing on testing pharmaceutical components and drug products. Under general supervision, the role may require proficiency in supporting formulation, improving and validating methods, and performing testing according to compendial pharmacopeia.
Responsibilities
- Be proficient in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, and titration
- Possess general knowledge of cGMP and FDA requirements
- Perform stability testing for GMP and R&D finished products
- Conduct analytical testing of API, excipients, and components following compendial and validated methods
- Perform analytical method validation and method transfer with minimum supervision
- Follow company’s SOPs, STPS, and comply with safety regulations
- Maintain detailed records of experiments in the laboratory notebook
- Timely communicate to supervisor(s) the obtained data and any issues arising during testing
- Analyze and interpret analytical data under minimum supervision
- Interpret specifications, standard operating procedures, and standard testing procedures
- Write/review protocols, reports, SOPs, and STPs applicable to analytical laboratory under supervision
- Work as a member of a team to achieve all outcomes
- Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements
- Perform all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
- Perform all other relevant duties as assigned
Requirements
- Bachelor’s degree (B.S.) in chemistry or a related field
- Master’s degree (M.S.)
- General statistical applications such as normal and T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, and correlation techniques
- Analytical chemistry and common instrumentation
- General understanding of HPLC, GC, Drug Release, UV, IR, Titration
- Using common computer software and analytical applications programs
- Writing and interaction in English
- At least two (2) to five (5) years experience in a pharmaceutical laboratory (B.S)
- At least zero (0) to three (3) years experience (M.S.)