Bioanalytical Scientist

Job Description
Position:  Bioanalytical Scientist – Method Development

Location:

Vapi, Gujarat
Company:  Nuvo Labs Pvt. Ltd. (Meril Life Sciences)

Role Overview
Nuvo Labs Pvt. Ltd. (Meril Life Sciences) is seeking a highly motivated  Bioanalytical Scientist  to support  bioanalytical method development and pharmacokinetic/pharmacodynamic (PK/PD) studies  for biologics and drug discovery programs. The candidate will be responsible for developing, qualifying, and implementing bioanalytical assays to measure  antibody concentrations and pharmacodynamic biomarkers  in preclinical samples.

Key Responsibilities
Bioanalytical Method Development
Develop and qualify  bioanalytical assays  for quantification of antibodies and pharmacodynamic biomarkers.
Establish and optimize bioanalytical methods including:
Ligand Binding Assays (ELISA / MSD)
Bridging Anti-Drug Antibody (ADA) assays
Pharmacokinetic (PK) assays
Target engagement assays
Perform assay development, optimization, and validation following  fit-for-purpose bioanalytical approaches .
Preclinical Sample Analysis
Support  PK/PD studies in preclinical species  by analyzing  serum or plasma samples .
Generate reliable data for  drug exposure and biomarker analysis .
Maintain proper documentation and ensure data integrity during experimental work.
Regulatory Compliance & Documentation
Develop assays compliant with  regulatory expectations and bioanalytical guidelines .
Maintain proper experimental records and documentation aligned with  GLP or regulatory requirements .

Required Qualifications
Master’s / PhD in Biotechnology, Biochemistry, Immunology, Life Sciences or related field.
Experience in  bioanalytical assay development for biologics or antibody-based therapeutics .
Hands-on experience with  ELISA, MSD, PK assays, ADA assays, or ligand binding assays .
Preferred Skills
Knowledge and practical experience in  mouse handling .
Experience working with  large animal models  is preferred.
Familiarity with  bioanalytical regulatory guidelines  is an added advantage.
Strong analytical, troubleshooting, and documentation skills.
Key Competencies
Strong understanding of  bioanalytical techniques for biologics
Ability to work in  cross-functional drug discovery teams
Strong  data interpretation and scientific reporting skills
Attention to  quality, accuracy, and regulatory compliance