Senior Chemist

Results-driven Senior QC Chemist with 5+ years of experience in pharmaceutical and GMP-regulated laboratory environments, specializing in analytical testing, method validation, and quality control. Demonstrated expertise in operating and troubleshooting analytical instrumentation including HPLC, GC, UV-Vis, and FTIR while ensuring compliance with cGMP, FDA, USP, and ICH guidelines. Skilled in performing routine and complex chemical analyses of raw materials, in-process samples, and finished products, with a strong ability to investigate out-of-specification (OOS) and out-of-trend (OOT) results.

Proven success collaborating with Quality Assurance, Manufacturing, and R&D teams to support product quality, regulatory compliance, and continuous improvement initiatives. Recognized for exceptional analytical thinking, technical leadership, documentation accuracy, and the ability to mentor laboratory personnel while managing multiple priorities in fast-paced pharmaceutical environments.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Perform routine and non-routine chemical analysis of raw materials, in-process samples, and finished products using validated analytical methods.
• Operate and maintain laboratory instrumentation such as HPLC, GC, UV-Vis, FTIR, and other analytical equipment.
• Review and interpret analytical data to ensure compliance with specifications and regulatory requirements.
• Troubleshoot analytical methods, instrumentation issues, and laboratory processes.
• Develop, validate, and transfer analytical methods in accordance with industry standards (e.g., USP, ICH, FDA guidelines).
• Prepare and review laboratory documentation, including test methods, protocols, reports, and SOPs.
• Ensure all laboratory activities comply with cGMP, safety, and company policies.
• Train and mentor junior chemists and laboratory technicians.
• Support internal and external audits and inspections.
• Maintain accurate and timely documentation in laboratory systems (e.g., LIMS, notebooks).
• Collaborate with cross-functional teams, including Quality Assurance, Production, and R&D.
• Assist with investigations related to out-of-specification (OOS) and out-of-trend (OOT) results.

QUALIFICATIONS:

• Bachelor’s degree in chemistry or related scientific field required;
  Master’s degree preferred.
• Minimum of 5+ years of experience in a pharmaceutical or GMP-regulated laboratory.
• Strong knowledge of analytical techniques such as HPLC, GC, and spectroscopy.
• Familiarity with cGMP, FDA, USP, and ICH guidelines.
• Strong analytical, problem-solving, and organizational skills.
• Ability to work independently and manage multiple priorities.
• Excellent written and verbal communication skills.