Manager - Viral Safety

Thornton Tomasetti; Mumbai; On-site; INR 3,000,000 - 6,500,000; Full time

Job summary

Abbott India, Mumbai Development Center, is seeking an Experienced Biological Safety expert to independently evaluate the safety of drug products derived from animal sources. You will lead adventitious agent risk assessments, molecular biology reviews, and zoonotic disease evaluations to ensure patient safety and product quality.

The role requires deep regulatory know-how (WHO, FDA where applicable), cross-functional collaboration with R&D, Quality, and Regulatory Affairs, and the ability to

Qualifications

• Strong expertise in biological risk assessment and molecular biology.
• Experience with adventitious agent risk assessment and regulatory expectations.
• Knowledge of global biosafety guidelines and cross-functional collaboration.

Responsibilities

• Biological safety assessment for drug products from animal origin; identify & mitigate risks.
• Review PCR data for pathogen detection; assess method suitability and reliability.
• Evaluate animal tissue sources; conduct supplier qualification and traceability reviews.
• Monitor zoonotic risks and advise on outbreak or risk scenarios affecting safety.
• Ensure regulatory compliance and contribute to documentation and audits.

Skills

Biological safety

Adventitious agent risk assessment

PCR-based detection

Zoonotic diseases

Education

MVSc/PhD in Microbiology or related field

Job description

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.

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.

Base Pay

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

Job Family

Product Development

Division

EPD Established Pharma

Location

India > Mumbai : Mumbai Development Center - EPD

Work Shift

Standard

Travel

Not specified

Medical Surveillance

Not Applicable

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Company Information

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

Equal Opportunity

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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