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.