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
