Sumit Bhati

About Sumit Bhati

I am a biotechnologist with over 7 years of expertise in bioprocess development and…

Experience

1. Scientific Officer

   Panacea Biotec

   Jul 2021 — Present · Mohali, IN

   Managed and operated a 600-litre production fermentor and a 15-litre seed fermentor for Hepatitis B vaccine production. Ensured the smooth operation and maintenance of fermenters’, adhering to standard operating procedures. • Oversaw the entire upstream manufacturing process for Hepatitis B vaccine, from inoculum preparation to fermentation and harvest and then centrifugation and Disruption of culture. Monitored critical process parameters, such as temperature, pH, and dissolved oxygen, to maintain optimal conditions for cell growth and protein expression. • Conducted routine sampling and analysis of fermentation broth to assess cell viability, productivity, and product quality. • Maintained strict adherence to quality standards and regulatory requirements throughout the manufacturing process. • Trained and mentored junior staff members on upstream manufacturing techniques, safety protocols, and good manufacturing practices (GMP). • Participated in Quality Management System (QMS) activities, including documentation, training, and audits. Ensured compliance with relevant regulatory standards, such as Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). • Collaborated with the quality assurance team to develop and revise standard operating procedures (SOPs), batch records, and other critical documents. Reviewed and updated documents to reflect process changes and improvements. • Worked closely with the validation team to perform risk assessments and develop validation strategies for new equipment, processes, and facility modifications. Taking Participation in internal and external audits, providing necessary documentation and supporting evidence. Addressed audit findings and implemented corrective and preventive actions (CAPAs) to ensure continuous improvement and compliance. •Contributed to change control processes, assessing the impact of proposed changes on upstream manufacturing and participating in change implementation activity.

Education

• Ambala College of Engineering & Applied Research

  BTech - Bachelor of Technology, Biotechnology

  2015 — 2019