Responsibilities:

1. Lead, mentor, and support a team of QC chemists, ensuring compliance with laboratory procedures and regulatory standards
2. Oversee analytical testing of raw materials, in-process samples, finished products, and stability samples
3. Investigate deviations and OOS results, implementing CAPAs and ensuring scientifically sound conclusions
4. Maintain and troubleshoot analytical instrumentation including HPLC, GC, FTIR, and UV-Vis
5. Ensure data integrity and proper documentation in accordance with GLP, cGMP, and regulatory requirements
6. Collaborate cross-functionally with QA, Manufacturing, and Regulatory teams to support product release
7. Participate in method validation, transfer, and verification activities
8. Support audits and regulatory inspections, ensuring lab readiness at all times
9. Train and develop laboratory staff on analytical techniques and compliance standards
10. Drive continuous improvement initiatives within the QC laboratory

Requirements:

1. Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related scientific field
2. 5+ years of pharmaceutical QC laboratory experience with strong analytical chemistry background
3. 1–3 years of leadership or senior-level experience within a QC lab
4. Hands-on experience with HPLC, GC, UV-Vis, FTIR, titrations, and wet chemistry techniques
5. Strong knowledge of cGMP, GLP, FDA, ICH, and USP guidelines
6. Experience with LIMS and chromatography data systems (e.g., Empower)
7. Proven experience with OOS, deviations, and CAPA investigations
8. Experience supporting audits and regulatory inspections
9. Strong leadership, communication, and problem-solving skills
10. Ability to work in a fast-paced, regulated manufacturing environment