Malini Mukherjee
Jamison,PA
Summary
Results oriented, people-first leader with broad experience in vaccine development, manufacturing and clinical trials. With experience from discovery to post commercial vaccines and expertise in cell therapy, I have lead teams to bring multiple products to successful launch with focus on quality and patient safety.
Experienced with strategic planning and project management. Utilizes leadership skills to drive team performance and operational excellence. Track record of delivering high-impact results through innovative problem-solving and effective communication.
Knowledgeable [Desired Position] with proven history of leading high-performing teams and executing strategic initiatives that drive organizational growth. Successfully directed cross-functional projects that resulted in significant process improvements and operational efficiencies. Demonstrated leadership and communication skills in fostering collaborative environments and delivering impactful results.
Overview
23
23
years of professional experience
Work History
Director, Material and Biophysical Characterization (MBC)
Merck & Co, Inc
West Point, PA
03.2025 - Current
- Workday manager for a team of 14 FTEs and 2 contractors and responsible for goal setting, SMART objectives, timely pipeline support and employee development plans (EDP) for all team members.
- Responsible for interfacing with 10 active pipeline vaccine programs on MBC deliverables around the development of biophysical characterization tools and the timely deployment of these tools for first-in-human clinical trials and IND filing.
- Responsible and accountable for deep characterization of above pipeline vaccines with focus on structure functional elucidation and establishing more robust potency assays through direct connection with clinical readout using tools like EMPEM (electron microscopy based polyclonal epitope mapping), solid state NMR and small angle X-ray scattering.
- Establishing a electron microscopy core team to address deep vaccine structural characterization questions across the pipeline.
Director, Vaccines Analytical Research and Development
Merck & Co, Inc
West Point, PA
12.2022 - 03.2025
- Workday manager for a group of 26 people (19 FTEs and 7 contractors), the team doubled under my remit through active recruitment externally and internally. I was responsible for individual goal setting and year-round accomplishments for the team in addition to guiding them to provide robust pipeline support and meet aggressive timelines for the franchise through SMART objective settings.
- Sponsor for Merck’s highest priority third generation Gardasil franchise and in this role, responsible for the strategy, design and timely implementation of analytical and CMC package for this program. Worked in this role across drug substance and drug product leads and with the analytical program lead (APL) to actively prioritize, resource and drive the program priorities and deadlines for Phase 1, 2 and 3 manufacturing.
- Sponsor for 3 novel adjuvants to be combined for first-in-human (FIH) Phase 1 trial for the Gardasil vaccine and responsible for analytical package development and readiness for adjuvant dose (release), GLP Tox and in-use stability and characterization packages. In this role, worked extensively with drug product teams to understand mechanism of action and potential degradation pathways for adjuvants in final formulation buffer.
- Drove method change and replacement of legacy release purity, potency and total protein methods for Gardasil through an analytical product life cycle (APLC) management team. In this work, drove multiple iterations of method development following ICH principles along with business alignment on specifications for this established franchise by engaging with Regulatory CMC and Value Chain Management Teams to define filing and cut over strategies for legacy products.
- Change agent in driving culture change in the department, bringing more engagement from team members, active ownership and accountability for program deliverables and thinking of long term and sustainable solutions (harmonized and platform approaches).
- Active participant in Merck due diligence activities and external contract manufacturing organization selection for pipeline vaccines.
Principal Scientist, Vaccines Analytical Research and Development
Merck & Co, Inc
West Point, PA
03.2022 - 12.2022
- Analytical SME in the development of potency, surrogate potency, and immune assays (infectivity, ELISA and ELISA counterparts using methods like Flow virometry and Octet) with medium and high throughput to support vaccines across modalities (live virus vaccines, virus like particles, conjugate vaccines, mRNA vaccines).
- Leading strategy to harmonize vaccines specifications for early phase products. Technical supervisor and mentor to 3 Merck FTEs. Introducing flow cytometry and flow virometry in the high throughput analytics group and leading method development for intracellular monitoring of cellular markers in upstream cell samples.
Associate Principal Scientist, Vaccines Process Development & Commercialization
Merck & Co, Inc
West Point, PA
10.2018 - 03.2022
- Pipeline Live Virus Vaccines In-Process Analytical Lead for VPDC
- People manager for a group of 14 (5 Merck FTEs and 9 contractors) – Was the workday supervisor responsible for providing year end feedback, putting together promotion package and project management for all Merck FTEs. Lead the team through several difficult program decisions during the Covid-19 pandemic while keeping morale high. Provided routine feedback to team, obtained feedback on personal leadership style, engaged in open communication with team and provided team coaching in navigating difficult situations. Was a tireless advocate for the team and was able to promote 3/5 FTEs to their next level roles within Merck. Kept routine track of EDPs for team members and provided opportunities within Merck to provide team with new opportunities in line with their EDP. Consistently upheld the importance of passion for science, exhibited by multiple publications, technical communications and conference presentations by the team members. Also maintained a strong mentoring relationship with all ELL contractors and actively engaged in talent management leading to several talented contract employees getting hired as FTEs.
- CMV pipeline vaccine in-process analytics lead – Lead team to perform in-process control (IPC) method qualification studies for 5 analytical methods, authored technical communication documents around these studies and lead tech transfer to site. Worked with statisticians to develop acceptance criteria around each method. Generated control charting strategy across instruments for internal and commercial site use. Lead data integrity and automation evaluation for selection of analytical instruments to support vaccine manufacturing and life cycle support in manufacturing sites.
- CMV pipeline vaccine new assay development and implementation lead – Lead the development of flow virometry based method to monitor virus particles for upstream and downstream process, qualified assay, lead tech transfer of new assay to commercial manufacturing site.
- CMV Mass Spectrometry assay – Worked with summer intern to identify biomarkers in production cells for peak harvest determination to maximize yield for upstream process (intern project, 2020, collaboration with Mass Spec SME).
- CMV vaccine analytical comparability lead – Lead comparability between Phase 3 and PPQ.
- Merck Ebola vaccine process performance qualification (PPQ) investigation analytical lead (work outlined in Ricci et al., 2021) – This assay is currently being utilized by the ERVEBO team for platform change studies.
- Merck experimental Covid-19 vaccines in-process analytical lead – Lead the process control strategy for the new vaccines in collaboration with process leads and CMC leads, performed process development and characterization studies for all analytical methods across upstream and downstream processes. Also developed flow virometry assay for the near real time monitoring of virus particles in upstream and downstream workflows.
- Live virus vaccines upstream process SME
- Pipeline Live virus vaccines analytical tech transfer lead across multiple programs
Senior scientist
Bellicum Pharmaceuticals
Houston, TX
04.2018 - 10.2018
- Senior member of a CAR T developing Biotech, involved in the design, conception and development of novel CAR products, with a focus on solid tumors. Heavily involved in the cloning and generation of new CAR T cells using proprietary molecular biology techniques. Subject matter expert in the implementation of novel tools to validate CAR T therapy cells in pre-clinical studies designed to tailor CAR products to targeted solid tumor sub types.
Faculty (current Adjunct Assistant Professor)
Center for Human Immunobiology, Baylor College of Medicine
01.2016 - 01.2021
- As leader of the CAR T high and super-resolution imaging team, conceived and directed the research plan to deliver essential modular studies on the in vitro testing of new CAR molecules using flow cytometry and high-resolution imaging. Also, provided ongoing research and technical support to studies in the Cell and Gene Therapy team at Baylor College of Medicine and M.D. Anderson Cancer Center in the development and functional testing of their new CAR pipeline.
- Current Editor for Frontiers in Immunology journal to screen and delegate peer review of primary scientific articles.
- Established imaging “toolbox” for high throughput in vitro testing of CAR products (Mukherjee et al., Molecular Therapy, 2017).
- Significantly reduced timelines and costs of in vitro CAR testing by performing thorough and broad spectrum testing of above established tools, also by performing validation studies in parallel using routine assays - key contributor to all aspects including meeting milestones with multiple large collaborative projects, training students and technicians, reporting for grants, timelines & ongoing technical support.
- Developed novel methods for evaluation of functionality of bi-specific and dual target CAR products by the application of in vitro imaging methods and analysis (Hegde, Mukherjee et al., JCI, 2016).
- Worked with the Business and Licensing Unit at BCM, gathered product development and licensing information and scientific insight in preparation for in-licensing of competitive products. Successfully filed patent applications for novel imaging-based CAR interrogation methods.
- Presented the concept of CAR synapse imaging as a valid tool for functional interrogation of CARs in multiple national and international conferences.
- Conducted teaching workshops to train academia and industry on the application of the novel in vitro tools for CAR evaluation (Innate Killer Summit, San Diego, July 2017).
Scientific Director of Microscopy Core
Center for Human Immunobiology, Baylor College of Medicine
01.2013 - 01.2016
- As manager of the imaging core facility at the Center for Human Immunobiology, oversaw, trained and directed all users (students, fellows and faculty) on the hands-on use and application of three high-end microscopes at the 4-million-dollar imaging facility. Also, was directly involved in the budgeting of the facility maintenance in grant money, as well as in writing core facility grants. Interviewed and hired applicants for the Center for Human Immunobiology.
- Wrote appraisal reports for all trainees directly involved in imaging-based projects.
- Performed routine evaluations on the performance of the machines.
- Conducted independent and collaborative research studies on projects involving therapy cell evaluation as well as evaluation of primary immunodeficiency diseases.
- Obtained independent grant funding for research.
Postdoctoral Fellow
Department of Pediatrics, Hematology and Oncology
01.2009 - 01.2013
- Worked on the broad goal of identifying the role of cell cycle proteins in novel mutations resulting in human cancers, using mouse models as a major tool. To this end, established and characterized two novel mouse models of Separase deregulation, both of which had highly robust cancer phenotypes of lymphoma/leukemia and Estrogen Receptor positive breast cancer, respectively. Specifically, identified key mechanistic pathways leading to Estrogen Receptor positive mammary tumors in mice and correlated pathways to human breast cancer progression using bioinformatics tools. These models have been added to the valuable cohort of mouse models of human disease (NCI mouse repository) that can be utilized for clinical trials in the future. Additionally, developed and characterized a mouse model to study the effect of Separase overexpression in osteoblast cells of the bone and characterized the effect of loss of Separase on HSCs in mice. Also, identified Separase as a key protein that is overexpressed in human glioblastoma and can be used as an early diagnostic marker for this disease.
- Established and characterized three novel mouse models evaluating the modulation of Separase expression in multiple tissues (Mukherjee et al., 2013, 2012).
- Performed collaborative research with multiple groups.
- Trained graduate and undergraduate students and technicians.
Graduate Student
Department of Biochemistry and Biophysics, UNC Chapel Hill
01.2003 - 01.2008
- Developed and characterized genetically engineered mouse models of triple negative breast cancer.
- Used genetic manipulation techniques to generate mammary gland-specific p53 and BRCA1 inactivation in mice, leading to the development of aggressive triple negative mammary tumors.
- Performed mechanistic studies to understand pathways involved in multi-step mammary gland tumorigenesis using microarray and genomic assays.
- Evaluated expression of potential biomarkers like cytokeratin 5 and 8/18 in Identified a novel microRNA signature in mouse BRCA1-null mammary tumors.
- Contributed to the development and characterization of a 3D matrigel culture system for primary mouse mammary epithelial cells.
Education
Doctor of Philosophy - Biochemistry & Biophysics
UNC Chapel Hill
01.2008
Bachelor of Science - Pharmacy
Jadavpur University
India01.2000
Skills
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
Accolades
- UNC graduate student merit fellowship, 2003
- NIH graduate student training grant award, 2004
- Susan G. Komen postdoctoral fellowship for breast cancer research, 2010
- Lymphoma and Leukemia SPORE Career Development Award, 2016
- ASGCT Best Presentation Award, 2016
- Immuno-Oncology Young Investigator's Forum (IOYIF) First Prize Winner, 2017
Publications
- Development and Characterization of an in-vitro cell - based assay to predict potency of mRNA-LNP-based vaccines, Patel N., Davis Z., Hofmann C., Vlasak J., Loughney JW., DePhillips, P., Mukherjee, M., Vaccines, 2023-07-01
- Rapid in-process measurement of live virus vaccine potency using laser force cytology: paving the way for rapid vaccine development, McCracken R., Al-Nazal, N., Whitmer, T., Yi S., Wagner, J.M., hebert, C.G., Lowry, M.J., Hayes, P.R., Schneider, J.W., Przybycien, T.M., Mukherjee, M., Vaccines, 2022-09-01
- Development of process analytical tools for rapid monitoring of live virus vaccines in manufacturing, Yi S, McCracken R, Davide J, Salovich D, Whitmer T, Bhat A, Vlasak J, Ha S, Sehlin D, Califano J, Ploeger K, Mukherjee M., Scientific Reports, 2022-09-01
- Flow virometry for process monitoring of live virus vaccines - lessons learned from ERVEBOTM, Ricci G, Minsker K, Kapish A, Osborn J, Ha S, Davide J, Califano J, Sehlin D, Rustandi R, Dick L, Vlasak J, Culp T, Baudy A, Bell E, Mukherjee M., Scientific Reports, 2021-04-01
- Human NK cell deficiency as a result of biallelic mutations in MCM10, Mace EM, Paust S, Conte MI, Baxley RM, Schmit MM, Patil SL, Guilz NC, Mukherjee M, Pezzi AE, Chmielowiec J, Tatineni S, Chinn IK, Akdemir ZC, Jhangiani SN, Muzny DM, StrayPedersen A, Bradley RE, Moody M, Connor PP, Heaps AG, Steward C, Banerjee PP, Gibbs RA, Borowiak M, Lupski JR, Jolles S, Bielinsky AK, and Orange JS., Journal of Clinical Investigation, 2020-08-01
- Cord blood NK cells engineered to express IL-15 and a CD19-targeted CAR show long-term persistence and potent antitumor activity, Liu E, Tong Y, Dotti G, Shaim H, Savoldo B, Mukherjee M, Orange J, Wan X, Lu X, Reynolds A, Gagea M, Banerjee P, Cai R, Bdaiwi MH, Basar R, Muftuoglu M, Li L, Marin D, Wierda W, Keating M, Champlin R, Shpall E, Rezvani K., Leukemia, 2018-02-01
- Quantitative Imaging Approaches to evaluate the CAR immune synapse, Mukherjee M, Mace EM, Carisey AF, Mamonkin M, Ahmed NM and Orange JS., Molecular Therapy, 2017-07-01
- RASGRP1 deficiency causes immunodeficiency with impaired cytoskeletal dynamics, Elisabeth Salzer, Deniz Cagdas, Miroslav Hons, Emily M Mace, Wojciech Garncarz, Özlem Yüce Petronczki, René Platzer, Laurène Pfajfer, Ivan Bilic, Sol A Ban, Katharina L Willmann, Malini Mukherjee, Verena Supper, Hsiang Ting Hsu, Pinaki P Banerjee, Papiya Sinha, Fabienne McClanahan, Gerhard J Zlabinger, Winfried F Pickl, John G Gribben, Hannes Stockinger, Keiryn L Bennett, Johannes B Huppa, Loïc Dupré, Özden Sanal, Ulrich Jäger, Michael Sixt, Ilhan Tezcan, Jordan S Orange, Kaan Boztug., Nature Immunology, 2016-12-01
- A Tandem CAR enhances T cell activation and mitigates antigen escape in glioblastoma by simultaneously engaging HER2 and IL13Rα2 in a bivalent immune synapse., Hegde M, Mukherjee M, Grada Z, Pignata A, Landi D, Navai SA, Wakefield A, Fousek K, Bielawowicz K, Chow K, Brawley VS, Byrd TT, Krebs S, Gottschalk S, Wels WS, Baker ML, Dotti G, Mamonkin M, Brenner MK, Orange JS and Nabil Ahmed., JCI, 2016-07-01
- Tonic 4-1BB Costimulation in Chimeric Antigen Receptors Impedes T Cell Survival and Is Vector Dependent., Gomes-Silva D, Mukherjee M, Srinivasan M, Krenciute G, Dakhova O, Zheng Y, Rooney CM, Orange JS, Brenner MK and Mamonkin M., Cell Reports, 2017-09-01
- Regulated Transgene Expression Reduces Fratricide and Permits 4-1BB Costimulation of CAR T Cells Directed to T-Cell Malignancies., Mamonkin M, Mukherjee M, Srinivasan M, Sharma S, Gomes-Silva D, Mo F, Krenciute G, Jordan S. Orange JS, Malcolm K. Brenner MK., Cancer Immunology Research, 2017-10-01
- MMTV-Espl1 transgenic mice develop aneuploid, estrogen receptor alpha (Erα)positive mammary adenocarcinomas., Mukherjee M, Ge G, Zhang N, Edwards DG, Sumazin P, Sharan SK, Rao PH, Medina D, Pati D., Oncogene, 2013-11-25
- Separase loss of function cooperates with the loss of p53 in the initiation and progression of lymphoma with damaged DNA and aneuploidy in mice., Mukherjee M, Ge G, Huang E, Zhang N, Fofanov V, Rao P H, Herron A, Pati D., PLoS One, 2011-07-01
- Overexpression and constitutive nuclear localization of Cohesin protease Separase protein correlates with high incidence of relapse and reduced overall survival in Glioblastoma Multiforme., Mukherjee M, Byrd T, Brawley V S, Bielamowicz K, Li XN, Merchant F, Maitra S, Sumazin P, Fuller G, Kew Y, Sun D, Powell SZ, Ahmed NM, Zhang N, Pati D., J Neurooncol., 2014-08-01
- Cooperativity of Rb, Brca1, and p53 in malignant breast cancer evolution., Kumar P, Mukherjee M, Johnson J P, Patel M, Huey B, Albertson DG, Simin K., PLoS Genet., 2012-11-01
Scientific Accolades
UNC graduate student merit fellowship 2003, NIH graduate student training grant award 2004, Susan G. Komen postdoctoral fellowship for breast cancer research 2010, Lymphoma and Leukemia SPORE Career Development Award 2016, ASGCT Best Presentation Award 2016, Immuno-Oncology Young Investigator’s Forum (IOYIF) First Prize Winner 2017
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Timeline
Director, Material and Biophysical Characterization (MBC)
Merck & Co, Inc
03.2025 - Current
Director, Vaccines Analytical Research and Development
Merck & Co, Inc
12.2022 - 03.2025
Principal Scientist, Vaccines Analytical Research and Development
Merck & Co, Inc
03.2022 - 12.2022
Associate Principal Scientist, Vaccines Process Development & Commercialization
Merck & Co, Inc
10.2018 - 03.2022
Senior scientist
Bellicum Pharmaceuticals
04.2018 - 10.2018
Faculty (current Adjunct Assistant Professor)
Center for Human Immunobiology, Baylor College of Medicine
01.2016 - 01.2021
Scientific Director of Microscopy Core
Center for Human Immunobiology, Baylor College of Medicine
01.2013 - 01.2016
Postdoctoral Fellow
Department of Pediatrics, Hematology and Oncology
01.2009 - 01.2013
Graduate Student
Department of Biochemistry and Biophysics, UNC Chapel Hill
01.2003 - 01.2008
Bachelor of Science - Pharmacy
Jadavpur University
Doctor of Philosophy - Biochemistry & Biophysics
UNC Chapel Hill