Lalit Kumar Email & Phone Number

Cambridge, Massachusetts, US

Boston, MA, US

Boston, MA, US

• Design, Develop and drive pre-clinical and clinical assays in regulated environment (GLP, GCLP, CLIA) and biomarkers strategies across functional therapeutic areas with emphasis in CRISPR/Cas9 edited stem cells based.
• Identify appropriate CRO to conduct in-vitro and in-vivo pharmacology studies and work closely with QA to conduct on-site technical audits to evaluate their scientific capabilities as well as compliance to.
• Lead internal teams and external partners/CROs through the development, qualification and validation of critical assays for clinical evaluation of novel cells-based therapeutics under tight timelines.
• Interact with KOLs and external collaborators.
• Support advancement of drug candidates from discovery to clinical trial execution by collaborating with the discovery and development functions to provide strategic biological, biomarker and clinical guidance.
• Contribute to authorship of non-clinical IND enabling safety study reports, invention disclosures, IND applications, and other regulatory documents.

Wilmington, Massachusetts, US

• Responsible for the coordination and oversight of genetically engineered murine model identification(genotyping)/creation, genetic monitoring of mouse and rat models, gene expression and PCR/qPCR based assay.
• Led internal R&D activities. Designed and validated qPCR based non-human primate (NHP) blood group typing assays which have been a source of steady revenue for the company. Designed and validated DNA isolation method.
• Managed project logistics with internal scientific staff and external contract research/resource organizations (CROs) to ensure adherence to study time lines and protocols.
• Led troubleshooting efforts for issue resolution.
• Participated in strategic business planning.
• Evaluated, recommended, and implemented latest technologies to improve productivity, increase efficiencies, and reduce costs. Qiacube HT for mid- to high throughput gDNA and RNA isolation. MALDI-TOF based MassARRAY®.

Served as an independent scientific and technical consultant to Biotech/Biopharmaceutical companies for development of cell based bioassays and in-vitro diagnostics (IVDs).

Boston, MA, US

• My research at the Boston Children’s Hospital was focused on studying molecular and genetic mechanisms governing hematopoiesis. I studied role of several genes in hematopoiesis and related immune disease by generating.
• Led research activities to achieve program and project-level goals.
• Planned and effectively communicated research goals and objective to junior scientific staff for the timely completion of research projects.
• Presented data in-house and at various national and international scientific meetings in a variety of formats (oral, poster and panel discussion).
• Assisted in writing and reviewing of SOPs, manuscripts and research grant proposals.
• Trained, supervised and mentored junior associates (research assistants, post-doctoral and clinical research fellows).

Boston, MA, US

• Led research projects aimed at the investigation of structure-function relationship of different signaling domains of adaptor proteins SLP-76 in the development and function of T cells and bone marrow derived mast.
• Designing and generating several different SLP-76 DNA expression constructs for the retroviral reconstitution of SLP-76 deficient BMMCs (derived from SLP-76 knockout mice).
• Designing and generating a series of tissue specific wild type and different mutant SLP-76 transgenic mouse models and breeding them in to the SLP-76 knockout background.
• In-depth phenotypic characterization of the reconstituted BMMCs and transgenic mouse models.The data generated in these studies resulted in one successful R01 grant from NIAID, NIH and publication of several.

Ph.D., Medical Biochemistry

M.Sc., Biotechonology

B.Sc. (H), Zoology