Role & responsibilities 1. Analytical Testing and Analysis:a. Analyze samples from various sources (raw materials, intermediates, finished products, and stability samples) to determine compound composition and quantities.b. Perform routine and complex analyses using HPLC, Prep HPLC, LCMS, UPLC, and Flash chromatography.c. Interpret analytical data and provide comprehensive reports of scientific results, including trend analysis and data summaries.d. Conduct testing, release, and documentation of raw materials, intermediates, and finished products, adhering to established specifications.e. Perform stability studies and analyze degradation products.2. Method Development and Validation:a. Develop and validate HPLC, LCMS, and other analytical methods for various drug products and chemical compounds, including forced degradation studies.b. Ensure methods are robust, reliable, and compliant with regulatory requirements (ICH guidelines, etc.).c. Write and review method validation protocols and reports.3. Instrument Management and Documentation:a. Perform routine calibration, maintenance, and troubleshooting of HPLC, LCMS, GC, and other analytical instruments.b. Prepare and maintain Standard Operating Procedures (SOPs) and Instrument Operating Procedures (IOPs).c. Maintain accurate and detailed documentation of all analytical activities, including raw data, instrument logs, and reports, in accordance with GLP/GMP.d. Participate in instrument qualification. 4. Quality Control and Compliance:a. Ensure all analytical activities comply with established quality control procedures and regulatory guidelines.b. Maintain awareness of and adhere to health and safety regulations, including chemical handling and waste disposal.c. Validate methods and equipment to ensure accuracy and reliability, participating in audits as needed.d. (Optional) Ensure compliance with cGMP and GLP guidelines.e. Participate in investigations of out-of-specification (OOS) results.5. Collaboration and Communication:a. Work collaboratively in cross-functional teams, including R&D, formulation, and regulatory affairs.b. Liaise with customers, staff, and suppliers as needed.c. Report scientific results effectively to stakeholders, including presentations and written reports.d. Participate in project meetings.Preferred candidate profile Technical Skills:a. Extensive hands-on experience with HPLC, Prep HPLC, LCMS, UPLC, and Flash chromatography.b. Proven experience in developing and validating HPLC and LCMS methods.c. Knowledge of instrument calibration, maintenance, and troubleshooting.d. Proficiency in data interpretation, statistical analysis, and documentation.e. Knowledge of stability testing. Knowledge:a. Strong understanding of analytical chemistry principles and techniques.b. Knowledge of raw materials, intermediates, finished product, and stability testing.c. Knowledge of preparing SOPs, IOPs, validation protocols, and reports.d. Knowledge of regulatory guidelines (ICH, etc.).e. (Optional) Knowledge of cGMP and GLP compliance.Soft Skills:a. Excellent analytical and problem-solving skills.b. Strong attention to detail and ability to maintain meticulous records.c. Excellent communication skills (both written and verbal).d. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).e. Ability to work independently and manage multiple tasks effectively.f. Strong team player Key Attributes:a. Accuracy and reliability in analytical work.b. Commitment to quality, compliance, and safety.c. Proactive and adaptable to new challenges and technologies.d. Strong organizational and time-management skills.e. Ability to learn and keep up to date with new analytical techniques and regulatory requirements.f. Ethical conduct.Perks and benefits