Role Objective

To oversee the development, qualification, validation, and technology transfer of bio-assays, binding assays, and impurity assays (HCP, HCDNA, SPR, ELISA, BET). The role involves leading analytical method transfers to plant operations, coordinating CRO activities, mentoring junior research associates, and ensuring strict compliance with regulatory guidelines, GDP, and data integrity standards.

KEY RESPONSIBILITIES

- Bioanalytical Method Development, Qualification & Tech Transfer:
- Perform continuous literature reviews and monitor pharmacopeia/regulatory guidelines to evaluate analytical methodologies and provide strategic inputs.
- Design and execute lab experiments to develop and optimize bio-assays, immuno-assays, host cell protein (HCP), host cell DNA (HCDNA), Protein A ELISA, Surface Plasmon Resonance (SPR), binding ELISA, and Bacterial Endotoxin Testing (BET).
- Qualify assays for reproducibility, prepare qualification/validation protocols, Standard Analytical Procedures (SAP), and technology transfer reports.
- Demonstrate assay processes to plant operators, observe technology transfer at manufacturing plants, and resolve post-transfer technical queries.
- Routine Testing & CRO Management:
- Perform and guide Research Associates (RAs) in testing non-GMP, non-release batches, and stability samples for internal laboratories.
- Review protocols and analytical reports from Contract Research Organizations (CROs).
- Coordinate external activities for Anti-Drug Antibody (ADA) assays, custom antibody generation, purification, and biotinylation for in-house HCP methods.
- Materials, Cell Banking & Equipment Management:




- Identify cell lines and antibody requirements; engage with vendors and supply chain teams to recommend reagents/equipment, raise Purchase Requisitions (PRs), inspect incoming materials, and manage inventory logs.
- Oversee cell-culturing, cryopreservation (cell banking), and routine passaging based on analytical testing needs.
- Manage calibration schedules, preventative maintenance, and breakdown support for laboratory equipment.
- Quality, Compliance & Audit Readiness:
- Ensure real-time, accurate recording of experimental data in lab notebooks/ELN following Good Documentation Practices (GDP) and strict data integrity standards.
- Design and conduct experimental studies to respond to regulatory queries in a timely manner.
- Initiate change controls for new equipment, execute Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) and Computer System Validation (CSV), and maintain lab readiness for internal/external quality audits.
- Write, modify, and update Standard Operating Procedures (SOPs) based on practical laboratory workflows.
- Team Leadership & Continuous Improvement:
- Conduct SOP and induction training for new Research Associates and direct junior team members on daily tasks.




- Provide technical inputs for CAPEX budget planning and implement continuous improvement initiatives to enhance lab efficiency and analytical throughput.

STAKEHOLDER INTERACTION
- Type of Interaction: Internal
- Interaction with: Plant Operations & Operators, Quality Control (QC) Team, Research Associates (RAs), Supply Chain & Procurement Team, Quality Assurance (QA) & Audit Teams.
- Nature of Interaction: Demonstrating assay processes, executing tech transfers, providing daily task direction, resolving post-transfer technical queries, raising PRs for materials, executing IQ/OQ/PQ/CSV, and maintaining quality audit readiness.

- Type of Interaction: External
- Interaction with: Contract Research Organizations (CROs), Reagent & Equipment Vendors/Suppliers.
- Nature of Interaction: Reviewing protocols/reports for ADA assays and custom antibody generation, engaging for reagent/equipment procurement, and coordinating instrument calibration/maintenance support.

JOB REQUIREMENTS Qualified Experience and Relevant Skills
- Experience: 5+ years of hands-on experience in bioanalytical assay development and validation within a biopharmaceutical or CRO environment.
- Skills: Technology transfer, CRO management, data integrity enforcement, GDP compliance, team mentorship, audit readiness, vendor coordination, and workflow optimization.
- Technical Expertise: Expertise in Bio-assays, Binding ELISA, SPR (Biacore/Octet), HCP, HCDNA, and BET assays; cell culturing, cell bank generation, and cell line maintenance; IQ/OQ/PQ, CSV, GDP, and regulatory audit compliance.

Academic Qualifications & Certifications:
- Educational Qualification: M.Sc. / M.Tech / Ph.D. in Biotechnology, Biochemistry, Bioanalytics, or Life Sciences.

📌 BRL - Bio-Immunoassay - (SRA-III) (India)
🏢 USV
📍 India