Bioanalytical Research Associate

Cadila Pharmaceuticals; Dholka; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Cadila Pharmaceuticals in Gujarat, India, is seeking a candidate responsible for developing, optimizing, and validating analytical chromatography methods. This role involves conducting product characterization, ensuring compliance with GMP and GLP standards, and supporting regulatory submissions.

Candidate will collaborate with R&D, Quality Assurance, and Manufacturing teams. Ideal for those with expertise in analytical techniques and strong documentation skills.

Responsibilities

• Develop, optimize, validate, and transfer analytical chromatography methods (HPLC, UPLC, GC).
• Perform method troubleshooting and continuous improvement activities.
• Conduct product characterization and impurity profiling using LC-MS.
• Interpret analytical data, prepare technical reports, and maintain documentation.
• Coordinate with external vendors and testing laboratories.
• Review and manage study protocols and reports from external partners.
• Ensure compliance with GMP, GLP, and internal quality standards.
• Support regulatory submissions with analytical data.
• Collaborate with R&D, QA, Regulatory Affairs, and Manufacturing teams.
• Investigate analytical issues and implement corrective actions.

Job description

Key Responsibilities

• Develop, optimize, validate, and transfer analytical chromatography methods (HPLC, UPLC, GC, etc.) in accordance with applicable guidelines and regulatory requirements.
• Perform method troubleshooting and continuous improvement activities to enhance analytical performance and efficiency.
• Conduct product characterization and impurity profiling using LC-MS and other advanced analytical techniques.
• Interpret analytical data, prepare technical reports, and maintain accurate laboratory documentation.
• Coordinate with external vendors, CROs, and testing laboratories for characterization studies and specialized analytical testing.
• Review and manage study protocols, reports, certificates, and related documentation from external partners.
• Ensure compliance with GMP, GLP, data integrity, and internal quality standards.
• Support regulatory submissions by providing analytical data, validation reports, and technical justifications.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams for project execution and technology transfer activities.
• Investigate analytical issues, OOS/OOT results, and implement corrective and preventive actions where required.