Analytical Scientist II

About the role

Laboratory position focused on the development and validation of analytical methodology to support research projects involving testing of pharmaceutical components and drug products. The role involves proficiency in formulation support, method improvement and validation, and compendial pharmacopeia testing under general supervision.

Responsibilities

• Demonstrate proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, and titration.
• Apply 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 minimal supervision.
• Follow company SOPs, STPs, and comply with safety regulations.
• Maintain detailed records of experiments in laboratory notebooks.
• Communicate data and issues to supervisors in a timely manner.
• Analyze and interpret analytical data with minimal supervision.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Write and review protocols, reports, SOPs, and STPs applicable to the analytical laboratory under supervision.
• Work as a team member to achieve outcomes.
• Operate in accordance with the company’s Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Perform all work in support of company 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.) is preferred.
• General knowledge of statistical applications such as normal and T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, and correlation techniques.
• Proficiency in analytical chemistry and common instrumentation.
• General understanding of HPLC, GC, drug release, UV, IR, and titration.
• Experience using common computer software and analytical applications programs.
• Strong writing and interaction skills in English.

Qualifications

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