About
Sanjeev Kumar
Principal Consultant
Sanjeev Kumar holds a Bachelor’s degree in Molecular and Cell Biology with a concentration in Immunology and Pathogenesis from the University of California, Berkeley, awarded in 2010.
In 2011, he commenced his professional career at Dendreon Corporation, where he manufactured Provenge, the world’s first FDA-approved autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer. Subsequently, he transitioned to Process Engineering, as a Provenge subject matter expert and served as a liaison between Research and Development and the Commercial Immunotherapy Manufacturing Facilities. Sanjeev actively participated in numerous process improvement initiatives and technology transfers.
In 2017, he joined a biotech startup called Nohla Therapeutics as the Manager of Clinical Manufacturing. During his tenure at Nohla, he spearheaded the development and management of the clinical manufacturing operations, overseeing the Phase II multi-dose manufacturing of NLA-101, an allogeneic expanded CD34+ stem cell therapy derived from umbilical cord blood, for the treatment of acute myeloid leukemia (AML) patients with chemotherapy-induced neutropenia. In recognition of his contributions, he was promoted to Associate Director of Manufacturing in 2018.
In November 2022, Sanjeev’s mother was diagnosed with Stage 4 gallbladder cancer. During her treatment, he noticed that there weren’t many organized resources and support available to gallbladder cancer patients. Inspired by the work of Stacie Lindsey and the Cholangiocarcinoma Foundation he founded the Gallbladder Cancer Foundation in January 2024. He currently serves as the President & CEO.
Services
- Expertise in both Autologous and Allogeneic cell therapies (Immunotherapy)
- FDA approved Commercial stage and Clinical stage startup experience
- Experience setting up manufacturing operations in a startup environment
- Pharmaceutical Batch Record Optimization
- CMO Site Evaluation and Selection
- Aseptic Process Validation experience
- Expertise with technology transfer from Research & Development to cGMP Commercial Manufacturing facilities
- Experience with Phase III technology transfer to a CMO
- Deviation support and root cause analysis
- Change Control
- Technical representative for supplier audits
- Batch Record Review
- Production Oversight (Person-in-plant)
- Identification of process improvements and implementation into a cGMP environment.