Quality

Experience

  • Deviation support and root cause analysis
    • Sanjeev possesses extensive experience in conducting root cause investigations and implementing corrective and preventative measures. His background in manufacturing equips him with the ability to think like an operator, while his Process Engineering expertise enables him to evaluate technical data effectively.
    • Change Control 
      • Sanjeev was the youngest member to serve on Dendreon’s Change Control Board as the Technical Representative. He has thorough knowledge of the change control process and how to effectively evaluate and implement changes in a cGMP compliant manner.  
    • Technical representative for supplier audits

      • At Dendreon, Sanjeev served as a technical representative, providing support for Quality supplier audits, which encompassed on-site inspections. 

    • Batch Record Review

      • Sanjeev, with extensive experience in manufacturing and managing clinical manufacturing operations, possesses a comprehensive understanding of batch record reviews.   

    • Production Oversight (Person-in-plant)

      • At Nohla Therapeutics, Sanjeev managed a manufacturing team and provided production oversight within the CMO. His experience at Nohla would enable him to serve as a PIP (Person in Plant) for other cell therapy manufacturing processes.  

    • FDA Inspection Readiness

      • Sanjeev served as a subject matter expert during multiple FDA inspections conducted at Dendreon. He possesses extensive experience interacting with the FDA. Furthermore, at Dendreon, Sanjeev assisted in training the FDA during annual immunotherapy training sessions. These sessions typically invited 15-20 FDA inspectors to the Seal Beach IMF to gain insights into Provenge and the intricacies of autologous cellular immunotherapy manufacturing and distribution processes.