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Senior Pharmaceutical Production Leader

3 weeks ago

Bengaluru, Karnataka, India Biocon Full time
About the Role

At Biocon, we are seeking a highly experienced Senior Pharmaceutical Production Leader to oversee our injectable operations. This is an excellent opportunity for a seasoned professional to join our team and drive operational excellence in a state-of-the-art facility.

Job Summary

The successful candidate will be responsible for managing our injectable production processes, ensuring compliance with regulatory requirements and maintaining high-quality standards. They will lead cross-functional teams, develop and implement process improvements, and ensure seamless execution of production plans.

Key Responsibilities
  • Lead and manage multiple filling lines, including isolator-equipped vial, prefilled syringe, and cartridge operations, ensuring efficient visual inspection and packing processes.
  • Supervise Lyophilizer operations with automatic loading and unloading systems, optimizing efficiency and reducing downtime.
  • Oversee compounding, filtration, filling, and packing activities, implementing quality control measures to prevent contamination and ensure product integrity.
  • Develop and train employees on aseptic operations, promoting a culture of safety and excellence within the team.
  • Manage regulatory audits and maintain facility readiness, ensuring prompt response to any observations or deficiencies.
  • Develop and execute end-to-end qualification strategies for equipment, facilities, media fills, and batches, ensuring compliance with regulatory requirements.
  • Coordinate pen device assembly and packing operations, optimizing supply chain logistics and minimizing delays.
  • Design and implement injectable facility setups, incorporating equipment, instruments, and processes that meet product and regulatory demands.
  • Procure materials required for production on time, ensuring timely start-up and smooth execution of media fills and batches.
  • Implement and maintain quality and operational tools, such as DMS, Trackwise, VLMS, and MES, streamlining workflows and enhancing data management.
  • Prepare and review URS, risk assessments, technical rationale documents for equipment and instruments, ensuring thorough understanding of operational risks.
  • Develop and approve process and packaging validation protocols or reports, batch manufacturing records, and other quality-related documents.
  • Promote Operational Excellence through project initiation and execution, driving continuous improvement initiatives across the organization.
  • Maintain documentation compliance and adherence to safety, health, and environmental norms, ensuring a safe working environment.
  • Drive productivity and efficiency gains by optimizing production processes, meeting or exceeding production targets while upholding quality standards.
  • Identify and address production issues promptly, resolving challenges through effective communication and collaboration with cross-functional teams.

As a senior leader at Biocon, you will have the opportunity to shape the future of our injectable operations, fostering a culture of innovation, collaboration, and excellence. If you are a motivated and results-driven professional with a passion for pharmaceutical production, we encourage you to apply for this exciting opportunity.

Requirements
  • 12-15 years of experience in pharmaceutical production, preferably in a leadership role.
  • Proven track record of leading cross-functional teams and driving operational excellence.
  • Strong knowledge of regulatory requirements, including cGMP, GDP, and ISO standards.
  • Ability to analyze complex problems and develop innovative solutions.
  • Excellent communication, leadership, and interpersonal skills.
Benefits
  • A competitive salary range: $120,000 - $180,000 per year.
  • A comprehensive benefits package, including medical, dental, and vision coverage.
  • Generous paid time off and holidays.
  • Professional development opportunities and education assistance.
  • A collaborative and dynamic work environment.