Job Description

Department -R&D – Bioanalytical / DMPK

Experience Required - 5–8 Years

Educational Qualification

• M.Sc. / M.Pharm in Life Sciences, Pharmaceutical Sciences, Biotechnology, Pharmacology, Biochemistry, or related discipline
• Preference will be given to candidates with specialization in Pharmaceutical Analysis, Pharmacology, Bioanalysis, or related fields

We are seeking an experienced and highly motivated candidate for the Bioanalytical & DMPK department within R&D. The ideal candidate should possess strong hands-on expertise in LC-MS/MS based bioanalytical method development and validation for small molecules, peptides, and large molecules, along with exposure to GLP and non-GLP bioanalytical studies.

The candidate should also have working knowledge and practical exposure to in-vitro ADME studies and a good understanding of DMPK functions supporting drug discovery and development activities.

Key Responsibilities

Primary Responsibilities – Bioanalytical

• Perform LC-MS/MS based bioanalytical method development and validation for:
  • Small molecules
  • Peptides
  • Large molecules / biologics
• Execute bioanalysis for GLP and non-GLP studies
• Develop, optimize, troubleshoot, and validate bioanalytical methods as per regulatory guidelines
• Perform sample preparation and quantitative bioanalysis using LC-MS/MS platforms
• Analyze pharmacokinetic and bioanalytical samples from preclinical studies
• Prepare method validation reports, study reports, SOPs, and technical documentation
• Ensure data integrity, compliance, and adherence to GLP/laboratory practices
• Troubleshoot analytical and instrumentation-related issues independently

Secondary Responsibilities – ADME / DMPK

• Conduct and support in-vitro ADME studies including:
  • Metabolic stability
  • Plasma protein binding
  • CYP inhibition/induction assays
  • Permeability assays
  • Plasma stability and solubility studies
• Support DMPK screening activities for discovery and development programs
• Interpret ADME/DMPK data and provide scientific inputs to project teams

Required Skills & Expertise

• Strong hands-on experience with LC-MS/MS instrumentation and bioanalytical workflows
• Expertise in bioanalytical method development and validation
• Experience handling small molecules, peptides, and large molecule bioanalysis
• Knowledge of regulatory expectations for GLP and non-GLP studies
• Understanding of pharmacokinetics, bioanalysis, and DMPK concepts
• Exposure to in-vitro ADME assays preferred
• Strong scientific data interpretation and technical writing skills
• Good communication and cross-functional collaboration abilities

Preferred Candidate Profile

• Candidates from pharmaceutical, CRO, or drug discovery organizations preferred
• Ability to independently manage bioanalytical studies and laboratory activities
• Strong problem-solving and scientific reasoning skills
• Experience with regulated bioanalytical environments will be an added advantage

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.