Senior Scientist

Role: Scientist

Location: Somerset NJ

Duration: 6 months

Perform routine analysis of finished products and raw materials, including testing stability samples under ICH conditions using techniques like HPLC, UPLC, GC, dissolution, hardness, and Karl Fisher. Ensure compliance with cGMP, SOPs, and regulatory guidelines while supporting product development and quality control.

Responsibilities:

• Conduct assays, dissolution, blend/content uniformity, and water content tests.
• Test excipients, APIs, and stability samples under various conditions.
• Perform in-process and finished product testing (QC release and data review).
• Operate lab instruments (HPLC, UPLC, GC, dissolution, UV, hardness testers, etc.).
• Follow SOPs, monographs, and procedures to perform and report tests.
• Conduct data trending, investigations (TrackWise), and SOP revisions.
• Support R&D, clinical, and commercial release testing.

Qualifications:

• Bachelor’s (required) or Master’s (preferred) in Analytical Chemistry/Pharmaceutics.
• 3 years of experience in pharmaceutical product development.
• Proficient with lab techniques (HPLC, GC, UV, KF) and GMP/ICH regulations.
• Strong communication, problem-solving, and organizational skills.