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 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.

1. 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.

1. Stability & Special Studies

- Knowledge and experience in:

- Stability Studies

- Photostability Studies

- Forced Degradation Studies
- Design, execute and monitor various analytical protocol studies.

1. Protocol Studies

Experience in designing, executing and monitoring studies such as:
- Multimedia Dissolution
- Photostability Studies
- Reconstitution Studies
- Tablet Splitability Studies

1. Documentation & Compliance

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

1. Quality Management

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

1. Regulatory & Guidelines

- Robust 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.

1. Software & Data Handling

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

- Empower

- Chromeleon

📌 ADL (Tech Transfer) (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai