Assistant Manager, Analytical Development

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a biosimilar/biologics analytics development specialist to oversee development, validation and sample analysis for PK, PD, ADA and NAb assays, and to review bioanalytical protocols, SOPs, analytical runs and final study reports.

The position requires a Master’s degree in life sciences and 3–5 years of hands-on experience with HPLC/UPLC, CE, UV and protein analytics, plus strong analytical development, writing and cross-functional collaboration skills.

Qualifications

• Master's degree in biotechnology, biochemistry, analytical chemistry or related life sciences.
• 3–5 years of biosimilar/biologics analytical development experience.
• Hands-on experience with physicochemical characterization techniques (HPLC/UPLC, CE, UV) and protein analytics.
• Strong understanding of analytical method development, qualification and troubleshooting.
• Excellent technical writing, data interpretation and cross-functional collaboration.

Responsibilities

• Oversee development, validation and sample analysis for PK, PD, ADA, and NAb assays.
• Review bioanalytical protocols, SOPs, analytical runs and final study reports.

Skills

Analytical method development

Troubleshooting

Technical writing

Data interpretation

Cross-functional collaboration

HPLC/UPLC

CE

UV

Protein analytics

Education

Master's degree in Biotechnology/Biochemistry/Analytical Chemistry

Job description

• Oversee development, validation and sample analysis for pharmacokinetic (PK), pharmacodynamic (PD), anti-drug antibody (ADA), and neutralizing antibody (NAb) assays.
• Review bioanalytical protocols, standard operating procedures (SOPs), analytical runs, and final study reports.

Job Description

• Oversee development, validation and sample analysis for pharmacokinetic (PK), pharmacodynamic (PD), anti-drug antibody (ADA), and neutralizing antibody (NAb) assays.
• Review bioanalytical protocols, standard operating procedures (SOPs), analytical runs, and final study reports.

Qualifications

• Master's degree (M.Sc./M.Tech) in Biotechnology, Biochemistry, Analytical Chemistry, or a related life sciences field.
• 3 to 5 years of experience in biosimilar/biologics analytical development.
• Hands-on experience in physicochemical characterization techniques such as HPLC/UPLC, CE, UV, and protein analytics.
• Strong understanding of analytical method development, qualification, and troubleshooting.
• Good technical writing, data interpretation, and cross-functional collaboration skills.