Executive - Analytical Research & Development (Injectables)

Role & responsibilities

Key Responsibilities

Analytical Method Development

• Perform

  analytical method development

  for injectable formulations (liquid, suspension, lyophilized)
• Conduct

  assay, related substances, dissolution (if applicable), pH, clarity, particulate matter

  testing
• Support

  method optimization and troubleshooting

  during formulation development

Method Validation & Verification

• Execute

  analytical method validation / verification

  as per ICH, USP, EP, BP guidelines
• Prepare and review

  validation protocols and reports

• Support

  method transfer

  to QC or manufacturing sites

Stability & Routine Analysis

• Perform

  stability studies analysis

  for veterinary injectables
• Analyze samples from

  development, exhibit, and pilot batches

• Trend and interpret analytical data to support formulation decisions
  

Documentation & Compliance

• Maintain

  laboratory notebooks, raw data, and analytical reports

• Ensure compliance with

  cGMP, GLP, GDP, and Data Integrity (ALCOA+)

• Support

  regulatory documentation

  for US FDA / EU / ROW markets
• Participate in

  audits, inspections, and internal reviews

Cross-Functional Collaboration

• Coordinate with

  Formulation R&D, Quality Assurance, Production, and Regulatory Affairs

• Provide analytical support during

  technology transfer and scale-up

• Assist in

  investigations, deviations, and OOS/OOT

  related to analytical activities

Instruments & Techniques

• HPLC / UPLC
  
• UVVisible Spectrophotometer
  
• pH Meter, Osmometer
  
• Karl Fischer (Moisture)
  
• TOC (basic awareness)
  
• Particulate matter testing (for injectables)
  

Qualifications

Education

• M.Sc. (Analytical / Chemistry / Pharmaceutical Sciences)

  or

• B.Pharm / M.Pharm (Pharmaceutics / Analytical)

Experience

• 2–5 years

  experience in

  Analytical R&D – Injectable Formulations

• Experience in

  animal health / veterinary injectables

  preferred
• Exposure to

  regulated markets (US FDA / EU GMP)

  desirable

Key Skills & Competencies

• Strong knowledge of

  injectable analytical testing requirements

• Understanding of

  ICH, USP, EP guidelines

• Data integrity and documentation discipline
  
• Analytical thinking and problem-solving skills
  
• Ability to work independently and in cross-functional teams
  

Preferred candidate profile