Assistant Manager / Deputy Manager – Production (Biologics)

About the Role

We are seeking experienced professionals to join our Biologics Production team. This role is pivotal in overseeing end-to-end manufacturing operations for both mammalian cell culture and microbial fermentation platforms. You will ensure compliance with global regulatory standards, drive operational excellence, and lead teams in delivering high-quality biologics that make a difference in patients’ lives.

Key Responsibilities

• Production Operations
  • Lead day-to-day manufacturing activities for mammalian and microbial biologics.
  • Oversee upstream (cell culture/fermentation) or downstream (purification, filtration, chromatography) processes.
  • Ensure adherence to batch production records, SOPs, and validated processes.
• Compliance & Documentation
  • Ensure strict compliance with GMP, USFDA, EMA, MHRA, and other global regulatory requirements.
  • Review and approve production documentation, deviations, CAPA, and change controls.
  • Maintain audit readiness and support regulatory inspections.
• Team Leadership
  • Supervise and mentor production staff, fostering a culture of safety, quality, and accountability.
  • Coordinate with cross-functional teams including QA, QC, Engineering, and Supply Chain.
  • Drive training initiatives for biologics manufacturing best practices.
• Continuous Improvement

• Identify and implement process optimization opportunities for yield, efficiency, and cost-effectiveness.
• Support technology transfer, scale-up, and new product introduction activities.
• Champion initiatives for digitalization, automation, and lean manufacturing.

 Qualifications

• B.Tech / M.Tech / M.Sc / Ph.D. in Biotechnology, Biochemistry, Microbiology, or related field.
• 8–15 years of experience in biologics manufacturing with exposure to both mammalian and microbial platforms.
• Strong knowledge of upstream and downstream processes, aseptic techniques, and cleanroom operations.
• Hands-on experience with large-scale bioreactors, fermenters, chromatography systems, and filtration skids.
• Proven track record in handling deviations, CAPA, and regulatory audits.

 Skills & Competencies

• Deep technical expertise in biologics production.
• Strong leadership and team management skills.
• Excellent documentation and compliance orientation.
• Analytical problem-solving and decision-making ability.
• Effective communication and stakeholder management.

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