Altaf Kazi
Phoenixville,PA
Summary
Motivated cell & gene therapy enthusiast with hands on experience interacting with biopharma clients while providing end-to-end technical solutions & managerial support to execute complex CMC projects to enhances sales and increase company portfolio-based market demand. Efficient in team building, hiring talent, training scientist at different levels for business continuity and succession planning to meet business need
Overview
22
22
years of professional experience
Work History
Associate Director-Method Development (Cell & Gene Therapy)
Charles River Laboratories (CRL)
12.2020 - 05.2024
- Spearheaded the advancement of numerous analytical assays for global biopharma clients addressing Critical Quality Attributes (CQAs) such as safety, purity, identity, quantity, potency, and stability for biologics and cell gene therapy products
- Oversaw a team of 10-12 direct reports, leveraging strategic recruitment practices to assemble highly effective teams that met corporate business needs and succession milestones with a retention rate of over 90%
- Utilized Salesforce data analysis in collaboration with sales and marketing departments to drive strategic planning for acquiring new clients which led to an expansion of the company's assay portfolio by introducing 4-5 new assays, further supporting the achievement of quarterly sales quotas
- Applied technical expertise to provide end-to-end solutions for clients during presales meetings, resulting in achieving project milestones and timelines within budget for 15+ complex sales projects annually
- Utilized technical expertise to develop analytical assays specifically catered towards biologics and cell & gene therapy, directly contributing towards supporting routine testing business with an annual revenue of $40-$50 million
- Provided business acumen to support tax consultants, leading to an annual reduction of $4-$5 million in federal taxes at CRL by accurately documenting internal project details and staff hours dedicated to assay development
- Collaborated cross-functionally to address complex customer needs within the Biopharma sector, resulting in a 25% increase in successful collaborative sales engagements
- Implemented targeted recruitment strategies to onboard new team members adept at assay development techniques, thereby enhancing overall lab efficiency and contributing to reduction in safety events
- Collaborated with sales team to identify gaps in the product portfolio, resulting in an increase in sales opportunities for Cell & Gene Therapy services
- Forecasted business needs and resources as part of the Senior Leadership Team to convey voice of the customer
- Led the design and certification process for a BSL2+ Lab tailored for cell & gene therapy research, showcasing business savvy by aligning the facility with industry-specific need
- Collaborated with cross-functional teams to implement innovative solutions for enhancing AAV transduction using chemical enhancers, resulting in a 50% increase in AAV potency assay based on transgene expression
- Designed Sizing assay for host cell DNA (HCD) by QF-PCR & viral genome titer by QF-PCR & ddPCR
- Collaborated cross-functionally to demonstrate the role and relevance of vector copy number (VCN) integration for LV- derived cell therapy products, contributing to successful customer consultations on molecular biology advancements.
Associate Consultant (Life Science Strategy and Competitive Intelligence)
IQVIA
01.2020 - 06.2020
- Monitored competitive landscape for pharma clients in breast cancer, gynecology, multiple myeloma, and melanoma
- Constructed bull's eye chart for melanoma and updated timelines
- Covered scientific conference (AACR, ASCO) for preclinical and clinical assets
- Tracked clinical trial recruiting san timeline
- Conducted primary research and KOL interviews to derive implications and form recommendations
- Gathered insights on NTRK fusion based diagnostics for client and tracker for diabetes and biosimilars
- Conducted primary and secondary research, mapped patient journey for patient access program for recently approved rheumatoid arthritis biologic
- Inferred physician preferences due to Covid-19 pandemic for virtual detailing vs
- In-person visits and their impact on prescribing habits for recently approved sickle cell disease therapeutic.
Group Leader & CAR-T Scientist (CAR-T Process & Analytical Development)
Janssen/Eurofins Lancaster Laboratories
06.2018 - 01.2020
- Led a team of 14 direct reports in CAR-T & Lentivirus group, overseeing process development and analytical assays of cellular immunotherapies while managing storage and inventory and prioritizing routing of process development samples for analytical testing depending on urgency and need
- Maintained and managed SharePoint database and log of in-process generated samples for PCR, flow, VCN, and VSVG assays, ensuring accurate tracking of over 500 samples per month
- Reviewed and approved flow cytometry and other analytical assay ELNs used in cell therapy
- Developed and executed a robust process using Miltenyi MiniMACS Separator for positive selection & isolation of CD4+ and CD8+ T-cells utilizing affinity beads & magnetic separation columns, resulting in a 80% increase in T-cell purity
- Led expansion of lentivirus transduced cell and lead characterization of autologous and allogeneic CAR-T cells in G-Rex bioreactors using immunophenotyping
- Standardized processes for expansion of human γδ T-cells to develop manufacturing of allogeneic CAR-T cell platform in G-Rex cell culture devices using PBMCs
- Achieved almost >98% enrichment of human Vγ9/Vδ2 from leukopacks & purified PBMCs and developed a robust multi-color flow cytometry panel for immunophenotyping of human γδ T-cells
- Developed Lentivirus infectivity assay in a 24 & 96 well format for testing viral preparations generated during downstream processing using Operetta CLS High Content Confocal Image Analysis
- Ensured productivity and handle conflicts in a client interfacing environment
- Carried out monthly one-to-one meetings to trouble-shoot issues and set professional goals and reviewed quarterly, semi- annually & annual performance
- Collaborated with client leadership to set goals and deadlines to manage deliverables and recommended promotions and achievement awards based on performance and client feedback
- Ensured proper staff PPE compliance, completion of training and compliance in accordance with client specifications
- Conducted phone and in-person interviews to hire new talent for team building and complement existing team members.
Bioassay Scientist (GMP Bioassays)
Janssen/Eurofins Lancaster Laboratories
03.2016 - 06.2018
- Trained new analyst and helped in troubleshooting assay performance and trending issues
- Earned 4 Superlative Service Award for providing services exceeding client expectations, based on client feedback
- Nominated for Team Spirit Award for assisting client meet tight deadlines towards filing for new drug approvals
- Awarded Impact Award and Inspire Award in recognition of performance exceeding expectations
- Provided post-market analytical support for DARZALEX (Daratumumab) and next-generation Daratumumab studies
- Used FRET & cell-based bioactivity assays: CDC, ADCC & FRET (CD38 FcγRI, FcγRII & FcγRIIIa) as per SOPs guidelines
- Ensured GMP-compliant sample testing, Documentation, Validation, Qualification, and Tech Transfer of GMP test methods
- Trained and implemented robotic (TECAN) platform for high-throughput analytical testing of commercial Darzalex samples and carried out, calibration, Performance Qualification (PQ) for GMP compliance
- Reviewed and approved ELNS and tracked audit trails for GMP assay compliance
- Investigated quality deviations, out of specification (OOS) and Outlier results
- Actively participated with Q/A and the Quality Event Management (QEM) group & Corrective Action and Preventive Action (CAPA) plans to close events and deviations in TrackWise.
Pot-Doc/Research Specialist/Senior Research Investigator/Research Associate
University of Pennsylvania
12.2001 - 03.2016
- Helped win $400K+ federal grant from National Institute of Dental and Craniofacial Research (NIDCR) while establishing a critical link between loss of Melanoregulin (MREG) function and secretion of pro-vascular factions leading to choroidal neovascularization (CNV) and susceptibility to age-related macular degeneration (AMD)
- Provided crucial data for $500K+ funded grant from NIH (National Institute of Health) to study SP-A receptor and its role in surfactant biology
- Helped win $400K+ funding from NIH grant to study signaling pathway in human airway smooth muscle cells that lead to airway remodeling
- Proved increased expression of MREG mRNA n immune cells by endotoxin derived from dental pathogens (P
- Gingivalis)
- Molecular Epidemiology of Severe Sepsis in the ICU (MESSI) Study: Go-to technical person/led 3-member team in study aiming to predict acute organ dysfunction in sepsis and trauma patients and design personalized therapeutics for acute respiratory distress syndrome (ARDS) and sepsis
- Demonstrated increased levels of inflammatory meditators like IL-6, IL-8, and G-CSF, in neutropenic sepsis patients and a concomitant with higher risk of ARDS, Acute Kidney Injury (AKI), and death in immunocompromised patients
- Provided biomarker assay support/technical trouble shooting for clinical samples collected from patients at different stages of sepsis
- Ex Vivo Lung Perfusion Study: Supported study aiming to expand donor lungs numbers for transplant
- Used gene array to analyze lung biopsy samples and pinpoint molecular markers to select good donor lungs
- Coached summer and medical students on laboratory regulatory compliance and lab protocols
- Established a link between the angiogenic factor, VEGF receptor (KDR/Flt-1) and airway remodeling in HASM using microarray studies
- Demonstrated enhancement of matrix protein, Fibronectin by HASM cells in response to VEGF and pro-inflammatory mediators
- Demonstrated previously undiscovered connection that asthma-causing cytokines can induce secretion of pro-vasculogenic factors like Vascular Endothelial Growth Factor (VEGF) and (Matrix Metalloproteinases) MMPs by human airway smooth muscles (HASM)
- Established a link between the angiogenic factor, VEGF receptor (KDR/Flt-1) and airway remodeling in HASM using microarray studies
- Demonstrated enhancement of matrix protein, Fibronectin by HASM cells in response to VEGF and pro-inflammatory mediators.
Education
Master of Science in Engineering (MSE) in Technology Management -
UNIVERSITY OF PENNSYLVANIA SCHOOL OF ENGINEERING & THE WHARTON BUSINESS SCHOOL
Philadelphia, PA2014
PhD in Biochemistry -
UNIVERSITY OF MUMBAI
Mumbai, India1999
Skills
- Project Management
- Strategic leadership
- Analytical Thinking
- Coaching and Mentoring
Lifescienceconsultingexperience
- IQVIA, Associate Consultant (Life Science Strategy and Competitive Intelligence), Philadelphia, PA, 01/2020, 06/2020, Monitored competitive landscape for pharma clients in breast cancer, gynecology, multiple myeloma, and melanoma Constructed bull's eye chart for melanoma and updated timelines, Covered scientific conference (AACR, ASCO) for preclinical and clinical assets Tracked clinical trial recruiting san timeline, Conducted primary research and KOL interviews to derive implications and form recommendations, Gathered insights on NTRK fusion based diagnostics for client and tracker for diabetes and biosimilars, Conducted primary and secondary research, mapped patient journey for patient access program for recently approved rheumatoid arthritis biologic, Inferred physician preferences due to Covid-19 pandemic for virtual detailing vs. in-person visits and their impact on prescribing habits for recently approved sickle cell disease therapeutic
- Healthcare Company (UPENN Biotech Grp), Philadelphia, PA, Spring 2014, Evaluate the Pharma-payer rebate system, Researched the effect of different market variables on market size for therapeutic drugs in various channels, Carried out complex data visualizations in JMP & evaluated candidate statistical methods for account profitability, Presented recommendations to the senior executives of the company
- BioTech Company (UPENN Biotech Grp), Philadelphia, PA, Spring 2014, Evaluate the biomarker market for cardiac diagnostics in Heart Failure and Acute coronary syndrome Conducted interviews with medical doctors and researchers in the field, Evaluate Point-of-Care (POC) market using Graphene based biosensor in Cardiac care
- BioTech Company (UPENN Biotech Grp), Malvern, PA, Winter 2014, Evaluated the market potential for Ubiquitin related research reagents produced by a local life sciences company Carried out SWOT analysis, surveys, and interviews with KOL, Conducted PubMed analytics and market research to predict market potential for ubiquitin research
Publicationspresentations
Available upon request
Corecompetencies
GMP/GLP test methods, Potency bioassays (TK, CDC & ADCC), Cell & Gene Therapy landscape, CAR-T process development, Upstream & Downstream processing, AAV/Lenti genomic titer, QF-PCR, ddPCR, Cytokine & metabolite ELISA, Fluorescent Microscopy, Sequencing, Lentivirus infectivity titer, Tech transfer, Scientific Presentations, Salesforce, Pre & post-sales support, Technical SME, Client project management, Time management, Internal resource allocation, Hiring & managing direct reports, Financial modeling & budget, SWOT analysis, Competitive & Business intelligence, Primary & Secondary Research, Conference coverage, Confocal microscope, Quant Studio, Multi-mode plate readers Paradigm (BD) (for absorbance, fluorescence and luminescence redouts), Operetta for High content microscopy, Amnis Imagestream-Imaging Flow, Fluorescent Microscope, NC-202 Automated cell counter, Lonza Nucleofection, BioTek Cytation 5, BD FACSLyric Flow Cytometry
Timeline
Associate Director-Method Development (Cell & Gene Therapy)
Charles River Laboratories (CRL)
12.2020 - 05.2024
Associate Consultant (Life Science Strategy and Competitive Intelligence)
IQVIA
01.2020 - 06.2020
Group Leader & CAR-T Scientist (CAR-T Process & Analytical Development)
Janssen/Eurofins Lancaster Laboratories
06.2018 - 01.2020
Bioassay Scientist (GMP Bioassays)
Janssen/Eurofins Lancaster Laboratories
03.2016 - 06.2018
Pot-Doc/Research Specialist/Senior Research Investigator/Research Associate
University of Pennsylvania
12.2001 - 03.2016
Master of Science in Engineering (MSE) in Technology Management -
UNIVERSITY OF PENNSYLVANIA SCHOOL OF ENGINEERING & THE WHARTON BUSINESS SCHOOL
PhD in Biochemistry -
UNIVERSITY OF MUMBAI