Research Associate/Officer in Analytical Dept _Alivus Life Sciences

Alivus Life Sciences; Navi Mumbai; On-site; INR 700,000 - 900,000; Full time

Job summary

Alivus Life Sciences is seeking a skilled professional for analytical method development, validation, and regulatory support in Navi Mumbai. The role involves developing methods across HPLC, UPLC, GC, UV, FTIR, KF, and dissolution, with emphasis on optimization and troubleshooting for APIs and intermediates.

You will also contribute to method transfer, laboratory operations, and GDP-compliant documentation to support DMF/ANDA/CEP submissions and regulatory audits.

Qualifications

• Proven ability in analytical method development
• Experience with HPLC, UPLC, GC, UV, FTIR, KF, Dissolution

Responsibilities

• Develop analytical methods and optimize for API and intermediates.
• Validate methods per ICH Q2 and support transfer to QC/manufacturing.
• Operate and maintain analytical instruments with GMP data integrity.
• Generate analytical data for regulatory submissions and respond to audits.
• Prepare SOPs, reports, specifications, and development documentation.

Skills

Problem-solving

Regulatory compliance

Cross-functional collaboration

Communication & report-writing

Job description

Role & responsibilities

Analytical Method Development

• Develop analytical methods using HPLC, UPLC, GC, UV, FTIR, KF, Dissolution, and other analytical techniques.
• Conduct method optimization and troubleshooting for API and intermediate analysis.
• Perform forced degradation and stability-indicating method development studies.
• Establish impurity profiling and characterization strategies.

Method Validation & Transfer

• Execute analytical method validation as per ICH Q2 guidelines.
• Prepare validation protocols and reports.
• Support analytical method transfer to QC, manufacturing sites

Laboratory Operations

• Operate, maintain, and troubleshoot analytical instruments.
• Ensure laboratory compliance with data integrity and GMP requirements.
• Maintain analytical records, logbooks, and documentation.

Regulatory Support

• Generate analytical data for DMF, ANDA, CEP, and other regulatory submissions.
• Support responses to regulatory queries and audits.
• Review specifications, analytical procedures, and stability data.

Documentation

• Prepare SOPs, analytical reports, specifications, STPs, and development reports.

Ensure documentation complies with Good Documentation Practices (GDP).

Preferred candidate profile

Preferred Competencies

• Problem-solving and investigation skills.
• Regulatory compliance orientation.
• Cross-functional collaboration with R&D, QA, and Manufacturing teams.
• Effective communication and report-writing skills.