Analytical Scientist (HPLC/GC/LCMS)

About This Role

Perform project-oriented analytical assignments, accurately document experiments, and maintain laboratory equipment for ophthalmic drug products and/or drug substances.

Responsibilities

• Collaborate with the team to design, plan, and perform independently variety of project-oriented analytical assignments (method feasibility, qualification, development stability, Ad-Hoc studies) in a timely and efficient manner.
• Maintain accurate documentation of experiments and results/analytical findings in electronic lab notebook.
• Properly maintain laboratory equipment and instrumentation to ensure laboratory operational capability.
• Procure necessary chemical reagents, reference standards, and other components from appropriate sources.
• Independently compile, evaluate, and/or statistically analyze technical data.
• Participate, collaborate, and contribute at group and projects meetings by presenting and discussing data and designing follow-up experiments.
• Conduct work activities in compliance with all company internal requirements and with applicable regulatory requirements (GMP, USP, ICH guidelines).

Requirements

• Current knowledge and understanding of regulatory requirements and practices (GMP, USP, ICH guidelines).
• Familiar with analytical techniques such as HPLC/UPLC with various detectors (CAD, RI, UV/PDA, etc.), GC-FID, particle size distribution, physical appearance assessments, pH meter, turbidimeter, osmometer, viscosity measurements, rheometry for ophthalmic drug products and/or drug substances.
• M.S. in Analytical Chemistry or related discipline with minimum 2 years of experience OR B.S. in Analytical Chemistry or related discipline with minimum 3-5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation.
• Strong report writing, documentation and organization skills.
• Proficient using Word, Excel, and statistical programs for analytical data evaluation.

Qualifications

• M.S. in Analytical Chemistry or related discipline or B.S. in Analytical Chemistry or related discipline
• M.S. with minimum 2 years of experience or B.S. with minimum 3-5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation.

Nice to Have

• Working knowledge of phase-appropriate analytical development (method feasibility, validation, and stability programs).

Skills

* Required skills