Niraj Bhatt
Senior Manager Quality Control @CRISPR Therapeutics
Signup · Get unlimited contacts
WORK HISTORY
Senior Manager Quality Control @CRISPR Therapeutics
Framingham, MA, US
Supported QC activities related to the completion of 12 GMP batches within a single year, demonstrating efficient leadership and project management skills.Contributed to strategic planning for Quality Control (QC) readiness for in-process sample testing, release testing, and stability testing for CAR-T manufacturing, ensuring robust quality control activities throughout the production process.Spearheaded nine method transfer-qualification activities within a one-year timeline, showcasing adept skills in method development and transfer.Successfully implemented a Laboratory Information Management System (LIMS) for streamlined and efficient sample management of outgoing and incoming samples.Achieved project milestones through effective collaboration with various functions including manufacturing, MSAT, quality assurance, analytical development, process development, CMC, and regulatory affairs.Guided the team on good documentation and cGMP practices, ensuring adherence to industry standards.Drafted sections for IND filing, deviations, investigations, and change controls, demonstrating proficiency in managing and resolving issues in a compliant manner.Played a key role in building the QC team and facilitating the fast onboarding of new team members, contributing to a cohesive and skilled workforce.Proactively identified and troubleshooted problems in day-to-day QC operations, ensuring smooth and uninterrupted sample testing to support manufacturing processes.Motivated the team to enhance performance, driving them toward the achievement of program goals within a strict timeline.
EDUCATION
The Maharaja Sayajirao University of Baroda
Ph.D, Biochemistry
The Maharaja Sayajirao University of Baroda
Master's degree, Biochemistry
The Maharaja Sayajirao University of Baroda
Bachelor's degree, Botany, Zoology, Chemistry
ABOUT NIRAJ BHATT
I am a entrepreneurial and undaunted scientist driven by a purpose: advancing human health through innovative drug discovery and cell therapy.My scientific foundation spans both in drug discovery and translational development, with expertise in: cGMP-Analytical method development, qualification/Validation, Release, Stability testing, in-process sample testing. Cell-based bioassays CAR-T Cell Therapy Stem cell biology and iPSC platforms Cardiovascular and metabolic disorders Inflammation and immunologyMy passion for drug development began during my early career at Sun Pharma, where I contributed to preclinical drug-discovery programs for antihistamine molecules. Seeing one of the molecules we screened initially advance into Phase II clinical trials. This was a defining moment—it reinforced my commitment to developing therapies that can meaningfully impact patients’ lives.Throughout my career, I have consistently embraced complex challenges and delivered results across academia, CROs, and biopharma environments. I am recognized for my entrepreneurial, can do attitude, strong analytical skill, troubleshooting, cross-functional collaboration, and team leadership—qualities that enable me to execute high-impact programs efficiently.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.