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Work Background
Freelance (Self employed)Project Management Consultant
Jun. 2024Results-driven Project Management Consultant: Specializing in streamlining complex projects within the dynamic biopharma landscape, specifically focusing on cell & gene therapy, clinical trials, and clinical research.
Proven Track Record: Successfully managed projects exceeding $1.5M, consistently delivering on time and within budget, while adhering to stringent regulatory requirements (cGMP, ISO 13485).
Expertise in Regulated Environments: Deep understanding of FDA, Health Canada, and ICH guidelines ensures seamless project execution and compliance.
Cross-Functional Team Leadership: Adept at leading and motivating multidisciplinary teams, fostering collaboration and achieving shared objectives.
Data-Driven Decision Making: Leveraging advanced analytical skills (PLA, statistical analysis) to inform strategic decisions and optimize project outcomes.
Client-Focused Approach: Committed to exceeding client expectations through proactive communication, transparent reporting, and exceptional project delivery.
CCRMMSAT Scientist
Mar. 2022 - Apr. 2024Toronto, Ontario, Canada1. Actively involved in process development of CAR-T cell based immunotherapy & iPSC master cell banking 2. Prepared multiple 5 equipment and 3 process SOPs, 2 validation protocols and 5 manufacturing protocols
3. Authored Lean MBRs for CAR-T immunotherapy, tech transfer protocol, risk assessments for process & materials
4. Cross functional collaboration across the organization as a SME for process development & manufacturing
5. Worked on a project to determine the materials needed to create a specialized media for stem cell culture
6. Change control, equipment qualification and validation, working closely with supply chain for estimating ETA
SGSBiotech Scientist
Dec. 2020 - Feb. 2022Mississauga, Ontario, CanadaQC tested 100 samples for determining drug potencies through cell based assays
Determining the efficacy of gene therapy by flow cytometry, ELISA & PCR
SOP development, revision, validation & qualification studies as per cGMP guidelines
Working experience with TWD, LIMS, Good documentation practices (GDP), DoE, ISO13485
Conducted investigations, managed deviations/OOS/OOX, performed root cause analysis
Preparing documents for QA review, implementing changes. Deviations and Change Control programs
Working under close deadlines to meet client expectations during client interactions
Western UniversityResearch Scientist
Oct. 2019 - Nov. 2020Greater Toronto Area Metropolitan AreaIn this role, my research primarily focused on non-coding RNAs and their role within liver fibrosis. As glucose has the potential to activate non-coding RNAs, the hyper-activation of liver cells may have an impact on liver fibrosis. Published 1 review article.
KIIT University, School of Biotechnology Faculty Scientist
Oct. 2014 - Sep. 2019Bhubaneshwar Area, IndiaPrincipal investigator, developing full research scope, securing grant funding, and leading Post-Doctoral and Masters and collaborating with peers in the scientific community to complete research studies critical to furthering understanding of cancer and treatment options. Secured $90K in grant funding and led a project on “Role of miR-214 in modulation of chemoresistance in cervical cancer cells”. Investigating drug toxicity on hematopoietic stem cells.
Spearheaded an immunotherapy project involving the development of Chimeric Antigen Receptor T-cells to target the CD-20 antigen found on leukaemia cells using CRISPR/Cas9. T cell engineering, viability & proliferation studies. Conducted CTL assays to evaluate the efficacy of CAR T cells
Selection & Expansion of T cells using CliniMACS and bioreactor respectively. Secured $20K in funding for the immunotherapy project and developed one major publication.
Directed and managed a 15 day workshop on “Basic Techniques in Cell Biology and Immunology”.
Biotechnology Industry Research Assistance Council (BIRAC)Scientist
Nov. 2012 - Jul. 2014New Delhi Area, IndiaIn this position, my primary function involved evaluating research proposals for medical, agricultural, and other related projects to determine feasibility for funding, for this governmental funding arm. I shortlisted various proposals and presented my findings in front of a technical committee to determine the business value in offering funding. As an additional responsibility, I also conducted outreach to industry experts to organize forums to discuss drug development in greater detail. Among my accomplishments in this role, I: - Directed the full organization of 3 meetings on early drug development, biopharma development, and HPV vaccines to discuss and resolve various commercialization challenges. - Conducted an end-to-end analysis and managed a proposal from a biotech incubator proposing the establishment of a ground-breaking new facility for pre-clinical drug testing valued at $900K.
University of DundeePostdoctoral Scientist
Jan. 2009 - Sep. 2012As a Postdoctoral Scientist, I researched tactics to control the exact time of DNA replication by way of dependent kinases. I evaluated whether adding CDK inhibitors could be used to change replication timing. As a second project in partnership with the Drug Discover Unit, I screened 10,000 compounds to evaluate the potential of MCM inhibitors as effective anti-cancer drugs. I shortlisted 2 compounds with acceptable levels of cell-death.
ICGEBNRF Cancer Postdoctoral Fellow
Nov. 2007 - Dec. 2008Cape Town Area, South Africa
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