Bioanalytical Scientist – Method Development

Job Title: Bioanalytical Scientist Method Development (PK/PD & Immunoassays)

Location: Vapi

Company: Nuvo AI Pvt Ltd / Meril Life Sciences

Job Type: Full-Time

About the Role

We are looking for a highly motivated Bioanalytical Scientist to support bioanalytical method development and PK/PD studies for biologics and antibody-based programs. The candidate will play a critical role in developing and validating assays for pharmacokinetics, immunogenicity, and biomarker analysis.

Key Responsibilities

Bioanalytical Method Development

• Develop, optimize, and qualify bioanalytical assays to measure:
• Antibody concentration
• Pharmacodynamic (PD) biomarkers
• Establish and validate methods such as:
• Ligand-binding assays (ELISA / MSD)
• Bridging Anti-Drug Antibody (ADA) assays
• Pharmacokinetic (PK) assays
• Target engagement assays

PK/PD Study Support

• Analyze biological samples (serum/plasma) from preclinical studies
• Generate, interpret, and report PK/PD data
• Collaborate with in vivo and translational teams

Regulatory & Compliance

• Develop fit-for-purpose assays aligned with regulatory expectations (GLP/GCLP where applicable)
• Maintain proper documentation for method validation and sample analysis
• Ensure compliance with internal SOPs and regulatory guidelines

Preclinical Expertise

• Hands-on experience in mouse handling is required
• Exposure to large animal models (e.g., canine, NHP) is preferred
• Work closely with in vivo pharmacology teams

Required Qualifications

• MSc / M.Pharm / PhD in Biotechnology, Bioanalytical Sciences, Pharmacology, or related field
• 26 years of relevant experience in bioanalytical method development

Required Skills

• Strong expertise in:
• ELISA / MSD platforms
• PK/PD assay development
• ADA assay development
• Understanding of:
• Biologics and antibody-based therapeutics
• Preclinical study workflows
• Hands-on experience with biological sample analysis

Preferred Skills

• Experience with regulatory guidelines (GLP, GCP, or GCLP)
• Exposure to large animal studies
• Knowledge of bioanalytical software and data interpretation tools

Why Join Us

• Work on cutting-edge biologics and AI-driven drug discovery programs
• Collaborative research environment
• Opportunity to contribute to next-generation therapeutics development