PRAVIN S HUSHANGABADE

• Designed and commissioned a fully functional rodent isolator facility from concept to operation within ~12 months, in full compliance with CPCSEA and AAALAC standards.
• Led 100% validation and calibration of all critical facility systems and scientific instruments prior to go-live.
• Executed the first successful import of Jackson Laboratory breeders, enabling establishment of multiple foundation colonies at the Hyderabad site.
• Implemented 100% GDP-compliant documentation systems, SOPs, and record-keeping frameworks from Day 1.

• Led strategic planning for the greenfield establishment of the Jackson Laboratory rodent isolator facility in Hyderabad.
• Partnered with senior JAX leadership to finalize facility layout, isolator design, and operational workflows.
• Recruited, trained, and onboarded a cross-functional team (scientific, technical, operations) to support round-the-clock facility operations.
• Successfully defended AAALAC accreditation on first submission, receiving only 2 minor recommendations with no major non-conformities.

• Delivered end-to-end project execution, achieving full operational readiness within 4 months of initiation of animal operations.
• Prepared and submitted the AAALAC application within 2 months of starting operations—well ahead of typical timelines.
• Successfully cleared 100% of major client audits during the initial operational phase, enabling commercial supply of mice within 4 months.
• Currently leading capacity expansion planning to support increased colony size and future client demand.

Discovery Biology & Vivarium Operations Leadership Scientific Leadership Managerial

• Led strategic planning and execution of Discovery Biology programs, including early pharmacokinetic (PK) and toxicology studies, supporting multiple preclinical pipelines.
• Designed and reviewed GLP-compliant study protocols, ensuring scientific rigor, animal welfare, and regulatory adherence.
• Observed and audited pivotal in vivo study procedures, assessing data integrity, quality compliance, and animal welfare outcomes.
• Responsible for study design, data interpretation, and scientific decision-making in alignment with GLP and AAALAC standards.
• Established SPF breeding programs for transgenic rodent models, enabling reliable and scalable in-house supply.
• Served as an Advisory Member of the Institutional Animal Ethics Committee (IAEC), contributing to ethical oversight and protocol review.

• Provided strategic leadership for Discovery Biology and Vivarium functions, aligning scientific operations with organizational goals.
• Built and sustained courteous, collaborative cross-functional relationships with scientists, veterinarians, QA, and external stakeholders.
• Trained, coached, and mentored multidisciplinary teams, improving competency and compliance with GLP and AAALAC requirements.
• Fostered a high-performance, compliance-driven culture, resulting in improved study execution timelines and audit readiness.
• Championed a safe and ethical work environment by promoting regulatory standards, institutional policies, and best practices.

• Oversaw daily operations of a 35,000 sq. ft. vivarium facility, supporting Discovery Biology, PK, and toxicology studies.
• Managed a combined annual operating budget, consistently meeting budget targets through effective planning, cost control, and resource optimization.
• Planned and executed new operational and scientific strategies, resulting in measurable expansion of the VS (Vivarium Services) portfolio.
• Implemented and monitored EHS, biosafety, and animal care compliance programs, ensuring 100% regulatory adherence.
• Ensured operational readiness for regulatory inspections, internal audits, and client visits, maintaining strong compliance performance.

Isolator Facility Design, Site Operations & Business Enablement Scientific Leadership Managerial

• Designed and implemented a highly automated, technically advanced rodent isolator facility, enabling consistent, high-quality animal production.
• Provided scientific and technical expertise on animal models to support sales, marketing, and collaborative research programs.
• Directed veterinarians and technical teams on specialized production processes, ensuring scientific rigor and animal welfare.
• Controlled and optimized the Colony Management Program, ensuring genetic integrity, productivity, and compliance.
• Ensured full adherence to CPCSEA, AAALAC, and parent-site quality standards across all scientific and operational activities.
• Actively participated in operational and quality audits, supporting continuous improvement initiatives.

• Partnered with Senior Leadership Teams (SLTs) to plan and execute India-focused business and growth strategies.
• Led recruitment, onboarding, training, and development of high-performing scientific, veterinary, and operations teams.
• Acted as a key representative during customer visits, fostering trust and enabling potential collaborative programs.
• Provided clear direction and mentorship to supervisors and veterinarians, driving accountability and performance excellence.
• Collaborated closely with Human Resources to implement policies, address site-related issues, and support workforce planning.
• Built a culture of quality, compliance, and continuous improvement across the site.

• Managed end-to-end site operations, consistently meeting production targets aligned with customer expectations.
• Implemented standardized processes, procedures, and work instructions, ensuring disciplined execution across teams.
• Proactively managed variances in quality, performance, cost, and timelines, driving corrective and preventive actions.
• Oversaw service contract projects, ensuring scope adherence, quality delivery, and cost effectiveness.
• Managed site budgets and inventory planning in collaboration with Finance, recommending operational efficiencies and process improvements.
• Ensured strict implementation and monitoring of defined work instructions, sustaining audit readiness and operational control.

Preclinical Toxicology & Facility Operations Leadership (TFM Role) Scientific Leadership Managerial

• Partnered with Taconic Biosciences in 2011 to establish rodent breeding operations for Taconic mouse models in India, pioneering the first commercial supply of Taconic mice in the country.
• Led end-to-end setup of breeding infrastructure, regulatory alignment, and operational processes, enabling India’s first locally available commercial Taconic rodent models.
• Provided overall scientific oversight for Preclinical Toxicology programs, ensuring studies met GLP, regulatory, and registration requirements.
• Monitored and managed a full battery of preclinical toxicology studies, aligning execution with regulatory timelines and sponsor expectations.
• Responsible for study design, animal welfare, data interpretation, and scientific decision-making in accordance with GLP and regulatory standards.
• Conducted direct supervision and in-study observations of pivotal study procedures to assess quality compliance, protocol adherence, and animal welfare.
• Served as scientific liaison between Sponsors and internal scientific teams, ensuring clarity, accuracy, and effective project execution.

• Provided functional leadership across Veterinary Science, Quality Assurance, Preclinical Toxicology, Engineering & Maintenance, Archives, Test Item Control, and IT as Technical Facility Manager (TFM).
• Built and maintained strong client relationships, supporting business development and helping sponsors formulate toxicology sourcing strategies.
• Acted as primary project coordinator between Sponsors and internal business teams to ensure scientific alignment and timely delivery.
• Demonstrated consistent leadership through hands-on involvement, accountability, and continuous operational improvement.
• Strengthened team cohesion and performance through mentoring, training, and active participation in team development initiatives.

• Oversaw day-to-day operations of multiple critical facility functions, ensuring operational efficiency and regulatory compliance.
• Planned and managed staff rotas, maintaining high service levels while optimizing labor utilization and controlling payroll costs.
• Developed and communicated project plans, milestones, and deadlines, ensuring on-time and high-quality project completion.
• Guided teams on inventory management and resource utilization, supporting uninterrupted study execution.
• Ensured effective documentation, archiving, and test item control, supporting audit readiness and data integrity.
• Supported business operations by handling client communications, resolving issues promptly, and contributing beyond defined responsibilities to ensure team success.

• Conducted pre-clinical in-vivo pharmacokinetic (PK) studies for New Chemical Entities (NCEs).
• Performed potency testing in mice (B6D2F1 strain) for large protein and biologic molecules.
• Executed GLP-compliant in-vivo toxicology studies in rodents for both NCEs and large protein therapeutics.
• Certified Radiation Safety Officer, ensuring compliant handling and use of radioactive materials in preclinical studies.
• Oversaw study conduct, data generation, and interpretation in accordance with GLP, regulatory, and ethical standards.

• Served as a Member of the Institutional Animal Ethics Committee (IAEC), contributing to ethical review and regulatory oversight of animal studies.
• Provided scientific and operational supervision of animal husbandry practices within the vivarium, ensuring high standards of care and welfare.
• Coordinated health monitoring and sentinel programs, maintaining colony health and biosecurity.
• Mentored and guided technical staff in study execution, animal handling, and compliance requirements.

• Managed import and procurement of laboratory animals, including quarantine management and controlled release into study areas.
• Led preparation, review, documentation, and archival of facility records and raw data, ensuring audit readiness and data integrity.
• Developed, implemented, and maintained SOPs governing vivarium operations, study conduct, and compliance.
• Ensured seamless coordination between study teams, veterinary staff, and facility operations to support on-time project delivery.

• Conduct and reporting of In-vivo pharmacokinetic studies in rodents and dogs
• Analysis and interpretation of Toxicokinetic/pharmacokinetic data
• Supervision of animal husbandry practices as per AAALAC
• Maintain Health Monitoring program of rodents and dogs used for pharmacokinetic studies.

• Member of the Institutional Animal Ethical Committee (IAEC).
• Rodent and non-rodent Animal house In-charge.
• Health monitoring of Management rodents according to CPCSEA guidelines
• Oral PK studies for tablet, capsule coated drug
• Preparation of SOP’s, Study protocols, Study report & presentation.