Responsibilities:

1. Perform analytical and wet chemistry testing in accordance with approved SOPs and regulatory requirements.
2. Conduct routine and non-routine testing of raw materials, in-process samples, and finished products.
3. Record, analyze, and report test results; identify and escalate atypical or out-of-specification (OOS) results.
4. Review and revise laboratory procedures, testing methods, and documentation as needed.
5. Support internal audits and maintain inspection-ready laboratory status.
6. Assist with instrument qualifications, method validations, and process validations.
7. Collaborate with formulation, filling, and packaging teams to support manufacturing operations.
8. Train junior analysts on laboratory techniques, SOPs, and compliance standards.
9. Participate in investigations and assist with corrective and preventive actions (CAPA) as needed.

Requirements:

1. Bachelor’s degree in Chemistry (preferred) or related science with coursework in General, Organic, and Analytical Chemistry.
2. 2–3+ years of analytical chemistry experience in an FDA-regulated pharmaceutical manufacturing environment.
3. Strong hands-on experience with wet chemistry techniques and laboratory instrumentation.
4. Working knowledge of cGMPs, GLPs, and FDA regulations.
5. Experience reviewing laboratory documentation and supporting regulatory audits.
6. Ability to manage multiple priorities in a fast-paced manufacturing laboratory.