Analytical Scientist II

DescriptionJob Summary:

Laboratory position which involves development and validation of analytical methodology in support of the research projects involving testing of pharmaceutical components and/or drug products. Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.

Job Responsibilities

Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
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 compedial and validated methods
Perform analytical method validation and method transfer with a minimum supervision.
Follow company’s SOPs, STPS and comply with safety regulations.
Maintain detailed record of experiments in the laboratory notebook.
Timely communicate to supervisor(s) the obtained data and any issues aroused during testing
Ability to analyze and interpret the analytical data under minimum supervision.
Interpret specifications, standard operating procedures, and standard testing procedures.
Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under the supervision.
Works as a member of a team to achieve all outcomes
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
All other relevant duties as assigned

QualificationsJob Requirements

Education

Bachelor’s degree (B.S.) in chemistry or related field
Master’s degree (M.S.)

Knowledge, Skills and Abilities

General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, 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

Experience

At least two (2) to five (5) years experience in pharmaceutical laboratory (B.S)
At least zero (0) to three (3) years experience (M.S.)