Walk-in || Officer/ Executive/ senior Executive/Assistant Manager

JOB DESCRIPTION ANALYTICAL DEVELOPMENT

Company: Lyrus Life Sciences
Department: Research & Development – Analytical Development
Job Title: Executive / Senior Executive / Assistant Manager – Analytical Development
Location: Hoskote, Bengaluru, Karnataka
Experience: 3–8 Years
Employment Type: Full-Time

1. Job Purpose

To perform analytical method development, method validation, and analytical testing for pharmaceutical formulations and support product development, stability studies, and regulatory documentation in accordance with applicable quality and regulatory requirements.

2. Key Responsibilities

• Develop, optimize, and validate analytical methods for pharmaceutical drug products and APIs.
• Perform analytical testing using HPLC, UV-Visible spectrophotometer, dissolution apparatus, and other relevant laboratory instruments.
• Develop and optimize methods for assay, related substances, dissolution, content uniformity, and other applicable quality parameters.
• Conduct forced degradation studies and support evaluation of stability-indicating analytical methods.
• Perform method verification, method transfer, and robustness studies, as applicable.
• Support pre-formulation, formulation development, pilot batches, and stability studies in coordination with Formulation R&D.
• Prepare and execute analytical protocols, validation reports, method development reports, and stability reports.
• Review chromatograms, analytical data, calculations, and laboratory records to ensure accuracy and compliance.
• Investigate analytical discrepancies, atypical results, and out-of-specification results in accordance with approved procedures.
• Maintain laboratory instruments, calibration records, logbooks, and relevant documentation.
• Ensure compliance with GMP, GLP principles where applicable, internal SOPs, and laboratory safety requirements.
• Coordinate with Quality Assurance, Formulation R&D, Regulatory Affairs, and other relevant departments.
• Support preparation of analytical data and technical documents for regulatory submissions, as required.

3. Educational Qualification

• M.Pharm in Pharmaceutical Analysis, Quality Assurance, or a relevant specialization is preferred.
• M.Sc. in Analytical Chemistry or a related discipline may be considered based on relevant pharmaceutical analytical development experience.

4. Experience Required

• 3–8 years of relevant experience in pharmaceutical Analytical R&D or Analytical Development.
• Practical experience in analytical method development and validation for pharmaceutical formulations.
• Experience in HPLC analysis, dissolution testing, and stability studies.
• Exposure to generic formulation development and regulatory documentation is preferred.
• Experience in method transfer, forced degradation, and impurity profiling will be an advantage.

5. Technical Skills Required

• Hands-on experience with HPLC and analytical method development.
• Knowledge of UV-Visible spectrophotometry and dissolution testing.
• Understanding of assay, related substances, impurities, and stability-indicating methods.
• Knowledge of analytical method validation parameters, including accuracy, precision, specificity, linearity, range, robustness, and detection/quantitation limits, as applicable.
• Familiarity with ICH guidelines and applicable pharmacopoeial requirements.
• Understanding of GMP documentation, data integrity, and laboratory procedures.
• Ability to interpret analytical data, troubleshoot chromatographic issues, and prepare technical reports.

6. Key Competencies

• Strong analytical and problem-solving skills.
• Attention to detail and accuracy in laboratory work.
• Good documentation and report-writing skills.
• Ability to plan and execute experiments independently.
• Effective communication and coordination with cross-functional teams.
• Ability to manage multiple projects and meet development timelines.