423619 Endotoxin rFC Microbiological Program Sr Manager MSAT (Open)

Company Overview

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Job Summary

The Sr Manager for the Endotoxin rFC microbiological program will lead the transition from animal-derived reagents to recombinant Factor C (rFC) in endotoxin testing methodologies. This role is crucial for aligning with the organization's strategic goals and ensuring the successful execution of projects across various divisions, including Analytical Science for Large Molecules, Small Molecules, and Vaccines.

Responsibilities

• Collaborate with internal and external partners to facilitate the transition to recombinant systems at all internal sites and Contract Research Organizations (CROs) / Contract Manufacturing Organizations (CMOs).
• Collect, analyze, plan, and align studies for endotoxin testing, including sample organization and shipment management.
• Author study plans and reports in compliance with organizational requirements, ensuring adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Coordinate with laboratories for outsourced endotoxin analyses, including setting up study protocols and managing sample collection and shipment.
• Negotiate contracts with CROs and manage project budgets in accordance with organizational standards.
• Set and track SMART objectives to ensure program execution aligns with organizational priorities, identifying and mitigating risks throughout the project lifecycle.

Qualifications

• Bachelor's degree in a relevant scientific field (e.g., Biology, Biochemistry, Microbiology).
• Strong knowledge of endotoxin testing methodologies and regulatory requirements.
• Experience in project management, including budget management and contract negotiation.
• Proficiency in data analysis and report writing.
• Excellent communication and interpersonal skills for collaboration with internal and external stakeholders.
• Familiarity with GMP and GDP practices, as well as data integrity rules.
• Ability to build strategic product roadmaps and prioritize laboratory work effectively.

Preferred Skills

• Advanced degree (Master's or PhD) in a relevant scientific discipline.
• Experience in method development and validation for endotoxin testing.
• Knowledge of recombinant technologies and their application in microbiological testing.

Experience

• Minimum of 5-7 years of relevant experience in microbiological testing, project management, or related fields.

Environment

• Hybrid work mode, with a typical work setting located at Bengaluru Luxor North Tower.

Salary

• Estimated salary range: ₹6,500,000.

Growth Opportunities

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Benefits

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