ADL (Tech Transfer)

Job highlights

• 3-8 years experience with B.Pharm/M.Pharm/M.Sc./B.Tech; expertise in analytical method development, validation, transfer per ICH guidelines; hands-on with HPLC, Dissolution, UV, FTIR; skilled in stability, photostability, forced degradation studies; proficient in Empower and Chromeleon software
• Perform analytical method verification, optimization, validation, transfer; conduct analytical troubleshooting; execute stability and protocol-based studies; maintain GLP/GDP compliance; handle LIR & QMS activities; ensure regulatory adherence; frequent travel for method validation and transfer

Job Title: ADL (Technology Transfer)

Location: Mumbai

Experience: 3-8 Years

Qualification: B.Pharm / M.Pharm / M.Sc. / B.Tech

Department: ADL-Technology Transfer)

Job Description

Job Purpose

To support and execute analytical development activities for formulation products, including analytical method verification, optimization, validation and transfer, along with analytical troubleshooting, stability studies and protocol-based studies in compliance with ICH, GLP, GDP, FDA and EMA guidelines.

Key Responsibilities

1. Analytical Method Development & Validation

• Perform method verification, method optimization, method validation and method transfer as per ICH guidelines.
• Support analytical troubleshooting related to formulation products and analytical methods.
• Travel frequently to different locations/sites for method validation, method transfer and analytical troubleshooting activities.

2. Instrument Handling

• Hands-on experience with analytical instruments including:

• HPLC

• Dissolution Apparatus

• UV-Spectrophotometer

• FTIR

• Ensure proper utilization and handling of analytical instruments as per established procedures.

3. Stability & Special Studies

• Knowledge and experience in:

• Stability Studies

• Photostability Studies

• Forced Degradation Studies

• Design, execute and monitor various analytical protocol studies.

4. Protocol Studies

Experience in designing, executing and monitoring studies such as:

• Multimedia Dissolution
• Photostability Studies
• Reconstitution Studies
• Tablet Splitability Studies

5. Documentation & Compliance

• Prepare, review and maintain analytical protocols, reports and logbooks.
• Ensure compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Maintain analytical documentation in accordance with applicable procedures and regulatory requirements.

6. Quality Management

• Experience in handling LIR & QMS activities.
• Ensure analytical activities are performed in compliance with established quality systems.

7. Regulatory & Guidelines

• Strong knowledge of relevant ICH guidelines.
• Good understanding of FDA and EMA guidelines related to analytical activities.
• Ensure analytical activities and documentation comply with applicable regulatory expectations.

8. Software & Data Handling

• Computer literacy with hands-on experience in analytical data handling software such as:

• Empower

• Chromeleon