Analytical Scientist II

Job 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 companys 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

Qualifications

Job Requirements

- Education

Bachelors degree (B.S.) in chemistry or related field

- Masters 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.)