ADL (Tech Transfer)

Navlakha Management Services; Mumbai; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Navlakha Management Services in Mumbai seeks an ADL (Technology Transfer) professional with 3-8 years of analytical development experience. The role requires B.Pharm/M.Pharm/M.Sc./B.Tech and involves method development, validation, transfer and troubleshooting across analytical platforms.

You will handle HPLC, dissolution, UV-Vis and FTIR instruments, support stability studies and ensure GLP/GDP-compliant documentation and data integrity. Travel to sites may be required.

Qualifications

• Bachelor or master degree in pharmacy or science with relevant analytical development exposure.
• Experience in method verification, validation and transfer as per ICH guidelines.
• Knowledge of GLP, GDP and regulatory expectations for analytical work.

Responsibilities

• Develop, verify, optimize, validate and transfer analytical methods.
• Troubleshoot analytical issues and support stability studies and protocol-based work.
• Travel to sites for method validation, transfer and troubleshooting activities.
• Operate analytical instruments in line with SOPs and regulatory requirements.
• Design and monitor studies including dissolution and photostability related work.
• Document protocols, reports and logbooks with GLP/GDP compliance.
• Maintain quality systems and ensure data integrity in analytical activities.
• Keep up-to-date with ICH, FDA and EMA guidelines relevant to analytics.

Education

B.Pharm

M.Pharm

M.Sc.

B.Tech

Tools

HPLC

Dissolution Apparatus

UV-Spectrophotometer

FTIR

Empower

Chromeleon

Job description

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