Summary
Overview
Work History
Education
Skills
Transformative Global C-Suite Leader | CMC Development Expert | Yale Fellow
Selected Achievements
POSTDOCTORAL RESEARCH & FELLOWSHIPS
Timeline
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HEMANT KUMAR

Shrewsbury,USA

Summary

Respected for propelling performance across the full gamut of biopharmaceutical companies, from startups to Fortune 500 global pharmaceutical powerhouses such as Merck and Lonza. Recognized as an expert in developing customized CMC strategies, internationally renowned for delivering revolutionary breakthroughs that save lives, maximize revenue potential, and ensure quality multimodal drug manufacturing worldwide. Proven track record in building mission-driven, top-performing teams that fuel growth, explore uncharted territory, eclipse ambitious goals, and advance the world\'s understanding of cancers and other life-threatening diseases.

Overview

25
25
years of professional experience

Work History

Advisory Board Member

Helix Biotech Inc.
01.2024 - Current
  • Company Overview: Full-service nanoparticle development and manufacturing CDMO serving customers with R&D, Pre-Clinical, and Clinical project needs including design & custom mRNA Synthesis, Oligonucleotides, and LNP Formulation Development & Screening
  • Defined and implemented company portfolio and product development strategy supporting growth, sales of LNP / mRNA services offered to clients and partners
  • Established the vision and strategy for the eQMS implementation and Portfolio, Programs and Alliance Management (PPAM) function for multiple drug development client programs and alliances

Principal Consultant / Owner

F2 BIOSOLUTIONS LLC
01.2023 - Current
  • Company Overview: Consulting firm providing tailored CMC and regulatory due diligence services for biologics, cell and gene therapies, and vaccines
  • Founded specialized consulting firm focused on solving critical regulatory and manufacturing scalability challenges for biotech companies at the forefront of innovation within cancer, viral, and infectious disease sectors
  • Provide C-level strategic, operational, and clinical advice to advance biotech companies’ research and therapy production efforts by navigating highly regulated industry and influencing study design
  • Readied PE-backed, optogenetic and diabetes gene therapy late-stage clinical company for phase3 clinical trials and commercialization for revolutionary gene therapy with fast-track FDA designation
  • Formulated CMC strategy and unblocked bottlenecks in external manufacturing/product development processes
  • Designed and implemented gene therapy product manufacturing processes in
  • Led quality technical remediation efforts addressing numerous FDA483 observations resulting in clinical hold for CAR T-cell therapy company, ensuring compliance and progress towards clinical trials
  • Designed and implemented Revive - MbD (Mfg
  • By Design) strategy for accelerated product manufacturing of Bi-specific Antibody Drug Conjugate (ADC) and Peptide Drug Conjugates (PDC) delivery to treat rare muscular disease and NSCLC cancer via Lipid Nanoparticles (LNP)

Strategic Advisor & Member Manufacturing Board

ARCTURUS THERAPEUTICS, INC.
04.2021 - 09.2023
  • Company Overview: Arcturus specializes in RNA medicines, with focus on treating infectious diseases, rare diseases, and cancer
  • Entrusted with sweeping oversight of CMC PMO—directing technical transfer, process scale-up, and validation of late-stage clinical mRNA medicines and vaccines and incorporating cutting-edge technologies, such as Lyophilized LUNAR lipid-mediated delivery, STARR mRNA Technology, and mRNA drug substance manufacturing
  • Capacitated delivery of100 million vaccine vials to BARDA for stockpiling
  • Introduced NanoAssemblr high-throughput platform technology to facilitate rapid scale-up of lipid nanoparticles for a Lunar saRNA COV-19 vaccine
  • Built80,000ft2 commercial-ready sterile flex fill finish facility to fulfill Asia Pacific countries’ government’s consortium for Pandemic Emergency Response readiness initiative
  • Led technical transfer and GMP clinical manufacturing of LUNAR-Cystic Fibrosis mRNA replacement therapy to restore CFTR expression and function in human bronchial epithelial cells and established clinical supply chain

Chief Technology and Manufacturing Officer / Executive Vice President

GENPREX, INC.
01.2021 - 01.2023
  • Company Overview: Pioneering gene therapies and developing adeno-associated virus (AAV)-based gene therapies targeting cancer and diabetes
  • Recruited by CEO to build tailored, comprehensive CMC organization that would course-correct company to achieve phase3 readiness and avoid pivotal trials
  • Grew multidisciplinary team of5 to20+ across manufacturing, process development, quality control, logistics, and project management
  • Fostered collaborations with external research institutions and introduced innovative technologies, including revolutionary gene barcoding—a breakthrough process enabling drug delivery tracking after drug administration
  • Designed tailored CMC strategies for accelerated drug development, focusing on oncology pipelines
  • Pioneered development of novel cancer treatments, improving organ targeted LNP (85%+ gene delivery to targeted organs) while revolutionizing platform technologies and expanding oncology GT portfolio
  • Partnered with student of Nobel Laureate Bob Langer during development to integrate synthetic DNA vector (Doggy Bone - dbDNA) and enzymatic production—creating “Dual Gene Barcoded” dbDNA
  • Created game-changing dual gene therapy approach and optimized non-viral delivery methods, tackling long-standing challenges with delivery systems and formulation issues in lung cancer treatment
  • Enhanced transaction scalability and productivity for GXP manufacturing and accelerated FDA IND filing, fueling advancements in diabetes reversal research
  • Mastermind of “ReVive” CMC strategy and dual-plasmid platform creation
  • Optimized approval submissions50%, reduced clinical trial material production time20%, and prepared therapies for phase3 trials via development of customized “Acclaim” plan, targeting lung, breast, ovarian, and glioma cancers
  • Designed and implemented “Oligonucleotide Drug Conjugate” (ODC) platform technology for product development and manufacturing to treatment of breast and pancreatic cancer

Lead Portfolio Integrator and Alliance Management

ONCOIMMUNE THERAPEUTICS, INC. (Subsidiary of Merck & Co.; acquired2020)
12.2020 - 03.2021
  • Company Overview: Privately held, clinical-stage biopharmaceutical company developing treatments for inflammation suppression & COVID-19
  • Promoted several times during fast-track tenure with mandate to evolve manufacturing capabilities and positioned company as attractive investment opportunity for global pharmaceutical powerhouse, Merck
  • Served as clinical consultant after multibillion-dollar acquisition by Merck, assisting in integration efforts and providing strategic advice on manufacturing and technical aspects
  • Drove technical aspects of production, generating millions of doses of monoclonal antibody therapies
  • Explored monoclonal antibody CD24Fc’s potential for COVID-19-related inflammation suppression during race to alleviate breathing difficulties and reduce hospitalizations
  • Orchestrated post-merger integration efforts with Merck, overseeing technology transfer, late-stage manufacturing, and supply chain optimization for Saccovid (CD24Fc)
  • Championed FDA-approved roadmap for Biologics License Application submission, expediting regulatory approval

Vice President of Global Technology Operations (Interim)

RENTSCHLER ATMP LTD.
11.2019 - 06.2020
  • Company Overview: Subsidiary of Rentschler Biopharma SE, a manufacturing organization for biologics and advanced therapies
  • Led the charge into volatile gene therapy market within the U.S
  • For German biopharma company after acquisition of distressed facility in Massachusetts
  • Selected to advise on expanding manufacturing services for Pfizer and Takeda—from due diligence to facility acquisition and technology selection
  • Directed team of engineers, collaborating closely with key stakeholders to institute good manufacturing practice (GMP) manufacturing capabilities focused on Adeno-Associated Virus (AAV) Vectors for clinical trial supply at CGT Catapult site
  • Contained spread of COVID by gaining U.S
  • And European Union approval of COVID vaccine under “Emergency Use Authorization” at beginning of pandemic—after resolving production issues for client mRNA COVID-19 vaccine
  • Spearheaded launch of startup venture and established Advanced Therapy Medicinal Product (ATMP) development and manufacturing capabilities within Cell and Gene Therapy Catapult facility in Stevenage, UK
  • Developed specialized CDMO (Contract Development and Manufacturing Organization) services tailored to meet company’s unique needs, expanding revenue streams and accelerating growth
  • Established GMP production suites, Process Risk Assessment and PPQ for gram-scale ADC payload production and multi-kilogram-scale production capacity to support clients accelerated submissions

Senior Vice President / Head of Global CMC, Technology, and Manufacturing Operations

ANAPTYSBIO INC.
01.2017 - 01.2019
  • Company Overview: Cutting-edge biotech firm specializing in pioneering immunology therapeutics for cancer, inflammation, and rare diseases
  • Reported to CEO and led global CMC teams through end-to-end drug product development across multiple modalities, emphasizing speed to patient and patient-centric product development
  • Powered rapid development and scale-up of key clinical trials’ materials, prepared regulatory submissions, and successfully resolved FDA holds to restart worldwide clinical trials
  • Helmed technical transfer and GMP manufacturing of Immuno-Oncology product Jemperli Anti-PD-1 antagonist to Tesaro, leading to a $5.1 billion acquisition by GSK
  • Pipeline leadership – Established the vision and strategy for the Portfolio, Programs and Alliance Management (PPAM) function and accountable for the overall framework for programs and external collaborations for pipeline advancement

Associate Vice President / Head of Global CMC, Bioprocess Development and Technical Services

MERCK & CO. INC
01.2016 - 01.2017
  • Company Overview: One of the largest pharmaceutical companies in the world with $59.3 billion in revenue and offices worldwide
  • Handpicked to orchestrate high-priority special projects while providing guidance on technical risk factors and remediation within the organization
  • Stood up new FLEX Factory, enabling flexible manufacturing crucial for accelerating GMP production
  • Achieved FDA’s accelerated approval of KEYTRUDA PD-1 inhibitor in treating certain cancers without Phase3 process development by resolving process and quality issues per FDA’s post-marketing commitment, ultimately reaching batch release rate of95%+ and $14B+ revenue
  • Led Merck’s ‘Biobetter’ (Biosimilar) program for ‘Insulin Glargine’ with short peptide conjugation to overcome drug resistance, and Protein PEGylation process for ‘Epogen’ to reduce degradation and enhance long-term stability and improved pharmacokinetic and pharmacodynamics characteristics of the final formulated drug

Senior Director / Head of Global CMC, Bioprocess Development and Technical Services

SANOFI INC.
01.2010 - 01.2016
  • Company Overview: Global pharmaceutical giant with $100 billion market capitalization and presence across100+ countries with100,000 employees
  • Marshalled team of120+ global employees through development of complex, multi-specific biologics, rare diseases, and AAV gene-therapy-based therapies
  • Ensured regulatory compliance and spearheaded engagements with FDA, EMA, and regulatory bodies
  • Ignited portfolio growth, reduced costs, and enhanced accountability across CDMO partnerships through design and implementation of integrated “Sanofi Global External Manufacturing Strategy.”
  • Averted plant lockdown and demonstrated a data-driven “State of Control” within aggressive timelines and budget constraints by drafting comprehensive MSAT Consent Decree Remediation Plan that gained FDA approval
  • Led global commercialization efforts for Dupixent, an Anti TL-4/IL13 mAb, achieving worldwide sales of $11B+
  • Invented next generation (serum free) Process Development and commercialization efforts for Fabrazyme, Cerezyme, and Lumizyme (rEnzyme replacement therapy), driving worldwide sales exceeding $11B

Director, Site Head of Manufacturing Sciences & Technology Operations

LONZA BIOLOGICS, INC.
06.2008 - 12.2009
  • Led commercial manufacturing of anti-cancer biologics ATrYn and Ontak while managing US government-contracted projects for bio-defense vaccines and therapeutics, including collaborations with BARDA and DoD
  • Establish yeast-based platform, XS Pichia, as an alternative to large scale production of biosimilars, biologics & vaccines

Head / Deputy Director of Global Vaccine Manufacturing Sciences & Technology Operations

SANOFI PASTEUR VACCINES, INC.
01.2002 - 01.2008
  • MSAT technical leader orchestrating vaccine process development for Menectra, Fluzone, and Dengvaxia vaccines
  • Piloted development of first Pandemic SARS-COVID1 (H1N1, H5N1) vaccine
  • Provided2M+ doses to US vaccine stockpile

Senior Scientist / Manager: Manufacturing Sciences & Biologics Technology Operations

CENTOCOR-ORTHO BIOTECH, INC., (Johnson & Johnson)
01.2000 - 01.2002
  • Realized40% productivity boost and revenue uptick for Procrit and Remicade

Education

Doctor of Philosophy - Biochemistry

J.N. Medical College

Executive Mini Master of Business Administration - undefined

Bentley University
Waltham, MA

Master of Philosophy - Biochemistry

J.N. Medical College

Graduate Certificate - Project Management

Lehigh University
Bethlehem, PA

Bachelor of Science - Biology and Chemistry

AM University

Skills

  • CMC Strategy
  • Manufacturing Scalability
  • Startups & Turnarounds
  • Business Diversification
  • New Product Portfolio
  • Multi-Site GMP Plant Ops
  • E2E Supply Chain
  • Technology & Innovation
  • Operations management
  • Strategic thinking
  • Innovative mindset
  • Data analytics
  • Cost reduction

Transformative Global C-Suite Leader | CMC Development Expert | Yale Fellow

  • EB1A-1 Green Card & U.S. Citizenship as “Exceptional Ability Scientist” | Resolved FDA Holds/Averted Shutdowns
  • Breakthrough Inventions: COVID Vaccines, Barcoding dbDNA, Serum-Free Delivery: Eliminated Bovine Serum FDA Safety Concerns | SME: Accelerated Development of Biologics, Gene Therapy, ADC Conjugates; Vaccines & Drug Delivery via LNP, AAV, Exosomes & PFS.

Selected Achievements

  • Implemented tailored CMC strategies that optimized multi-modality drug development and manufacturing processes, boosting operational efficiency and regulatory compliance.
  • Scaled development and enabled disbursement of100 million doses of Saccovid (CD24Fc) to Operation Warp Speed stockpile in the U.S., EU, and Asia.
  • Spearheaded30+ product launches, submitted35+ regulatory applications, and supplied10+ billion doses generating $5B revenue; raised $3B for early-stage biotech firms.
  • Led100+ multi-modal drug development initiatives—producing patent-pending vaccines and biologics with multibillion-dollar revenue potential with major CDMOs, including Wyeth Vaccines, JNJ, Sanofi, and Merck.

POSTDOCTORAL RESEARCH & FELLOWSHIPS

  • Yale University, School of Medicine: Howard Hughes Research Center | New Haven, CT
  • University of Rhode Island & CDC Center for Infectious Disease | Providence, RI

Timeline

Advisory Board Member

Helix Biotech Inc.
01.2024 - Current

Principal Consultant / Owner

F2 BIOSOLUTIONS LLC
01.2023 - Current

Strategic Advisor & Member Manufacturing Board

ARCTURUS THERAPEUTICS, INC.
04.2021 - 09.2023

Chief Technology and Manufacturing Officer / Executive Vice President

GENPREX, INC.
01.2021 - 01.2023

Lead Portfolio Integrator and Alliance Management

ONCOIMMUNE THERAPEUTICS, INC. (Subsidiary of Merck & Co.; acquired2020)
12.2020 - 03.2021

Vice President of Global Technology Operations (Interim)

RENTSCHLER ATMP LTD.
11.2019 - 06.2020

Senior Vice President / Head of Global CMC, Technology, and Manufacturing Operations

ANAPTYSBIO INC.
01.2017 - 01.2019

Associate Vice President / Head of Global CMC, Bioprocess Development and Technical Services

MERCK & CO. INC
01.2016 - 01.2017

Senior Director / Head of Global CMC, Bioprocess Development and Technical Services

SANOFI INC.
01.2010 - 01.2016

Director, Site Head of Manufacturing Sciences & Technology Operations

LONZA BIOLOGICS, INC.
06.2008 - 12.2009

Head / Deputy Director of Global Vaccine Manufacturing Sciences & Technology Operations

SANOFI PASTEUR VACCINES, INC.
01.2002 - 01.2008

Senior Scientist / Manager: Manufacturing Sciences & Biologics Technology Operations

CENTOCOR-ORTHO BIOTECH, INC., (Johnson & Johnson)
01.2000 - 01.2002

Executive Mini Master of Business Administration - undefined

Bentley University

Master of Philosophy - Biochemistry

J.N. Medical College

Graduate Certificate - Project Management

Lehigh University

Bachelor of Science - Biology and Chemistry

AM University

Doctor of Philosophy - Biochemistry

J.N. Medical College

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