Analytical Development Research Associate - Injectables

Alkem Laboratories; Navi Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Alkem Laboratories in Navi Mumbai seeks a senior analytical scientist to lead method development, validation, and transfer for injectable products. The role emphasizes peptide and suspension matrices, along with robust characterization studies and regulatory documentation.

You will apply QbD concepts, ensure cGMP adherence, and maintain comprehensive lab safety and documentation practices in a fast-paced analytical laboratory environment.

Qualifications

• Extensive experience in analytical method development and validation of injectable products.
• Proven experience with injectable, peptide, and suspension products.
• Demonstrated expertise in sameness and characterization studies for complex molecules.
• Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.
• Advanced skills in troubleshooting analytical methods and instruments.
• Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.
• Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
• Experience with stability testing and forced degradation studies for injectable products.
• Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.
• Responsible for practicing Good Documentation practice in department.
• Responsible for ensuring safety in Analytical Laboratory.

Responsibilities

• Exte nsive work exp in analytical method development and validation of injectable products.
• Proven experience with injectable, peptide, and suspension products.
• Demonstrated expertise in sameness and characterization studies for complex molecules.
• Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.
• Advanced skills in troubleshooting analytical methods and instruments.
• Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.
• Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
• Experience with stability testing and forced degradation studies for injectable products.
• Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.
• Responsible for practicing Good Documentation practice in department.
• Responsible for ensuring safety in Analytical Laboratory.

Skills

Analytical method development

Analytical method validation

Injectable products

Peptide products

Suspension products

Sameness and characterization

HPLC

GC

UV

Mass spectrometry

QbD

cGMP compliance

Documentation

Laboratory safety

Tools

HPLC instrument

GC instrument

UV-Vis spectroscopy

FTIR

KF titration

Mass spectrometry

Job description

1. Extensive work experience in analytical method development and validation of injectable products.

2. Proven experience with injectable, peptide, and suspension products.

3. Demonstrated expertise in sameness and characterization studies for complex molecules.

4. Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.

5. Advanced skills in troubleshooting analytical methods and instruments.

6. Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.

7. Familiarity with Quality by Design (QbD) principles and their application in analytical method development.

8. Experience with stability testing and forced degradation studies for injectable products.

9. Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.

10. Responsible for practicing Good Documentation practice in department.

11. Responsible for ensuring safety in Analytical Laboratory.