Immunogenicity & Large Molecule Bioanalysis

Biopatrika; Gujarat; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Biopatrika in Vadodara, Gujarat, seeks a Manager-2 to lead immunogenicity and large molecule bioanalysis programs. You will guide method development, analytical strategies, and biomarker assessments for monoclonal antibodies and biotherapeutics, ensuring regulatory alignment and data integrity.

The role requires hands-on lab execution across immunoassays (ELISA, MSD, cell-based assays) and strong collaboration with cross-functional teams to drive project milestones.

Qualifications

• M.Sc./M.Tech with 7–10 years of industry experience or Ph.D with 1–3 years.
• Strong immunology and regulated bioanalysis expertise required.
• Hands-on immunoassay and biomarker analysis experience.

Responsibilities

• Support discovery, preclinical and clinical development of biologics.
• Method development, reagent generation, and bioanalytical method validation.
• Lead projects; coordinate with other departments for execution.
• Draft protocols, validation reports, summaries, and regulatory documents.

Skills

Immunogenicity

Bioanalysis

ELISA

Flow cytometry

Regulatory compliance

Project leadership

Education

M.Sc./M.Tech in Biotechnology/Biochemistry/Pharmaceutical Sciences

Ph.D. in Immunology/Pharmaceutical Biotechnology

Tools

ELISA assays

Flow cytometry instruments

MSD platform

Job description

We are hiring!

Function: Immunogenicity & Large Molecule Bioanalysis Department: Biotechnology R&D Qualification M.Sc./M.Tech– Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline with 7–10 years of relevant industry experience, OR Ph.D. in Immunology, Pharmaceutical Biotechnology, or a related discipline with 1–3 years of relevant industry experience.

Position Title: Manager-2

Job Location: Vadodara, Gujarat

Job Description:

• To support the discovery, preclinical, and clinical development of biologics, including monoclonal antibodies, recombinant proteins, peptides, and other biotherapeutics.
• Hands on experience on method development, critical reagent generation, bioanalytical method validation, and study sample analysis for pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity (ADA/NAb), and biomarker assessments.
• Rhe role requires strong technical expertise in immunology, regulated bioanalysis, immunoassay optimization, data analysis, troubleshooting, and hands-on laboratory execution. Hands-on experience with ELISA, cell-based assays, MSD, flow cytometry etc.
• Ensure compliance with regulatory guidelines, including FDA, EMA, ICH, and GLP/GCLP requirements. Ensure data integrity and adherence to quality standards.
• Serve as a technical lead for assigned projects. Coordinate with other departments to facilitate project execution.
• Draft and review study protocols, method development reports, validation reports, technical summaries, and regulatory documents.

Dr Nitin Nage Ph.D.

Arnab Sinha Roy