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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

6. 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.

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

ADDITIONAL LOCATIONS:

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)