Manager - Viral Safety

Abbott; Mumbai; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Abbott in Mumbai, India seeks an experienced Biological Safety expert to independently evaluate safety of drug products from diverse sources including animal origin. The role demands strong expertise in biological risk assessment, molecular biology, and zoonotic disease evaluation.

You will contribute to decision making on product safety, supplier qualification, and mitigation of risks related to infectious agents, with cross-functional collaboration across R&D, QA, Regulatory and Procurement

Qualifications

• Advanced degree in Microbiology, Veterinary Science or related field with relevant biosafety knowledge.
• Experience with adventitious agent risk assessment and PCR-based pathogen detection.

Responsibilities

• Biological Safety Assessment for drug products.
• Carry out adventitious agents risk assessments for animal-origin products.
• Identify and evaluate risks from viral, bacterial, and prion contaminants.
• Develop risk mitigation strategies and provide scientific recommendations.
• Evaluation of sourcing/manufacturing changes and adventitious agent risk.
• PCR Data Review & Interpretation for pathogen detection and clearance.
• Review and interpretation of PCR assay data, including detection limits and data reliability.
• Collaborate with lab teams to troubleshoot and optimize testing strategies.
• Raw Material Source Qualification: assess animal tissue sources and supplier documentation.
• Monitor zoonotic risks and emerging infectious diseases and provide input during outbreaks.
• Ensure regulatory compliance with WHO, EMA, FDA guidelines and support regulatory documentation.

Skills

Biological safety

PCR data interpretation

Zoonotic risk assessment

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

MVSc/PhD in Microbiology or related field

Job description

Primary Job Function

Experienced Biological Safety expert to independently evaluate the safety of drug products derived from different sources including animal origin. The role requires strong expertise in biological risk assessment, molecular biology, and zoonotic disease evaluation. The candidate will contribute to decision making on product safety, supplier qualification, and mitigation of risks related to infectious agents.

Experienced Biological Safety expert to independently evaluate the safety of drug products derived from different sources including animal origin. The role requires strong expertise in biological risk assessment, molecular biology, and zoonotic disease evaluation. The candidate will contribute to decision making on product safety, supplier qualification, and mitigation of risks related to infectious agents.

Core Job Responsibilities

• Biological Safety Assessment
• Carry out adventitious agents risk assessments for drug products derived from animal origin.
• Identify and evaluate risks from viral, bacterial, and prion contaminants.
• Develop risk mitigation strategies and provide scientific recommendations.
• Evaluation of the sourcing/manufacturing process changes and subsequent adventitious agent risk for the product.
• PCR Data Review & Interpretation
• Review and interpretation of PCR assay data for pathogen detection and clearance.
• Assess method suitability, detection limits, and data reliability.
• Collaborate with laboratory teams to troubleshoot and optimize testing strategies.
• Raw Material Source Qualification
• Evaluate and approve animal tissue sources based on safety criteria.
• Review supplier documentation, including :
• Animal health and veterinary records
• Traceability and sourcing practices
• Slaughterhouse and processing conditions
• Perform risk-based supplier assessments.
• Zoonotic Risk Monitoring
• Monitor global and regional disease outbreaks with zoonotic relevance.
• Assess impact of emerging infectious diseases on raw material safety.
• Provide timely scientific input during outbreak or risk scenarios.
• Regulatory Compliance
• Ensure compliance with applicable global biosafety and regulatory guidelines (WHO, WOAH/OIE, EMA, FDA as applicable).
• Support preparation of regulatory documentation and responses.
• Contribute to internal audits and external inspections.
• Tackle regulatory queries pertaining to biological safety
• Documentation & Cross-functional Collaboration
• Prepare risk assessments, technical reports, SOPs, and justifications.
• Collaborate with R&D, Quality, Regulatory Affairs, Pharmacovigilance and Procurement teams.
• Present scientific findings to internal stakeholders and management.

Supervisory/Management Responsibilities

NA

Direct Reports

No

Indirect Reports

No

Position Accountability/Scope

• Accountable for biological safety risk management, adventitious agent assessment, PCR data evaluation, raw material qualification, zoonotic risk surveillance, regulatory compliance, scientific documentation, and cross-functional leadership to ensure patient safety, product quality and regulatory compliance.

Minimum Education

• MVSc/PhD in Microbiology, Toxicology, Molecular Biology, Veterinary Science, or related field.

Minimum Experience/Training Required

• Advanced degrees in Veterinary Sciences, Microbiology, Lifesciences, Biotechnology, Toxicology, Pharmacology, or a related field at least 10 years of experience
• Knowledge of biological safety, adventitious agent risk assessment, PCR-based pathogen detection, and zoonotic diseases.
• Understanding of global regulatory requirements, GxP, quality systems, and risk assessment principles.
• Experience in supplier qualification, raw material safety assessment, and traceability evaluation.
• Strong technical writing, documentation, and cross-functional communication skills.