Executive/ Sr. Executive/ Assistant Manager – Production (Biologics – Mammalian/ Microbial)

About Client

Leading Biopharma client having Biopharma, API and Formulations Business across regulated markets.

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 (Mabs) and microbial biologics.
  • Oversee upstream (cell culture/fermentation).
  • 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.