Analytical Scientist – Pharmaceutical (Method Development & Validation)

Job Title: Analytical Scientist – Pharmaceutical (Method Development & Validation)Location: Fairfield, NJ Department: Quality Control / Analytical R&DPosition SummaryWe are seeking a detail-oriented Analytical Chemist with strong experience in method development and validation using HPLC and GC techniques. This role supports pharmaceutical product development and quality control by designing, optimizing, and validating analytical methods in compliance with regulatory standards.Key ResponsibilitiesDevelop, optimize, and validate analytical methods for drug substances and drug products using HPLC, Dissolution, UV and GC Perform method validation activities in accordance with ICH guidelines (e.g., accuracy, precision, specificity, linearity, robustness). Conduct routine and non-routine analysis of raw materials, intermediates, and finished products. Troubleshoot analytical methods and instrumentation issues. Prepare and review technical documentation, including protocols, reports, SOPs, and test methods. Ensure data integrity and compliance with cGMP, GLP, and regulatory requirements. Support stability studies and impurity profiling. Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing. Maintain laboratory instruments, calibration, and preventive maintenance schedules. Participate in internal and external audits as needed. Required QualificationsBachelor’s or Master’s degree in Chemistry, Analytical Chemistry, or related scientific field. 2–3 years of experience in pharmaceutical or related industry. Hands-on experience with HPLC and GC method development and validation. Strong understanding of ICH, FDA, and cGMP guidelines. Proficiency in analytical data analysis and interpretation. Experience with chromatography software (e.g., Empower, Lab solutions). Excellent documentation and technical writing skills. Preferred QualificationsStrong analytical and problem-solving skills Attention to detail and data accuracy Effective communication and teamwork Time management and ability to meet deadlinesApplicationEmail your resume directly to snalluri@stirapharma.com