Summary
Overview
Work History
Education
Skills
Languages
Awards
Publications
Timeline
Generic

Maen Qadan

Orland Park,IL

Summary

Experienced leader with more than 20 years in biologics development, innovation, acceleration to market, technology transfer, manufacturing, and commercial operations support. Extensive experience in multiple modalities including vaccines, enzymes, mAbs, and gene therapy. Experienced in building strategy, restructuring, globalizing, divesting, and managing change in organizations. Strong business acumen with an MBA from a top business program. Head of the Research and Development team at CSL’s Illinois site, led the global bioprocess sciences team supporting all commercial plasma manufacturing across four continents, and saved life saving medicine worth more than $740 million. Led the design and development of next generation manufacturing at CSL and Eli Lilly and coauthored the industry leading CMC acceleration approach at Lilly. Established the best-in-class strategy for process robustness, monitoring, and CPV at BMS, and the overall strategy for Manufacturing Sciences & Technology at CSL. Supported the development and launch of multiple products including devices. Strong track record of successful interactions with FDA, EMA, and other regulatory agencies.

Overview

20
20
years of professional experience

Work History

Executive Director, Innovation & Pilot Plants, PPD

CSL Behring
10.2024 - Current
  • Leading the Research and Development team at the CSL Behring, Kankakee, IL site.
  • Restructured the Breakthrough Technology team across the US, Europe, and APAC, to drive purposeful innovation that brought cutting edge technologies into two next generation manufacturing processes to reduce COGS and increase throughput.
  • Accountable for plasma clinical manufacturing activities to scale up next generation manufacturing processes, produce clinical material for clinical trials, and prepare for launch where possible. The pilot plants are in Kankakee, IL and Marburg, Germany.
  • Leading an effort to integrate the power of quantum computing into pharmaceutical manufacturing in collaboration with an academic/industry conglomerate and CSL’s CTO.
  • Executive Director, Bioprocess Science & Pilot Plants, PPD Jan 2021- October 2024
  • Led the Research and Development team at the Kankakee, IL site. Responsible for developing and implementing a next generation process for a new clinical program.
  • Led the reorganization and globalization of Bioprocess Sciences (MS&T) to support manufacturing operations at all commercial sites across four continents. The team saved products worth $742 million in the previous fiscal year. Activities included deviation support, investigations resolution, root cause analysis, proactive process improvement, and leading life cycle management programs. The team was transferred to Operations in October 2024.
  • Collaborated with Operations to establish the technical governance and prioritization for life cycle management projects to assign resources and be flexible if emergencies arise.
  • Global head of plasma clinical manufacturing and scale up activities. Please see above.
  • Evaluated multiple external CDMOs following the CSL criteria and built collaborations with multiple external organizations.
  • Led the Enable GoDisc device program leading the clinical, CMC, commercial, regulatory, and quality teams internally, and in collaboration with our external partner, Enable Injections, to deliver a high-volume single-use infusion pump by 2027.

Research Advisor, Biologics Research and Development

Eli Lilly and Company
02.2016 - 01.2021
  • Established the business case, then built a cross functional team for next generation manufacturing of protein therapeutics, with a goal to reduce the cost of biologics gram to <$10, increase output to beyond 100 metric tons, and reduce CapEx by 75%. Represented this effort internally and externally.
  • Coauthored the guidance for next generation CMC approach on efficiency and speed of development, which culminated in supporting the advancing the Covid-19 mAbs in less than 8 months from gene sequence to EUA.
  • Led the late phase team to facilitate smooth regulatory submissions including INDs and BLAs. Led the effort to improve process characterization, small-scale model qualification, integrated control strategy, and our QbD approach in general. Supported the launch of multiple commercial biologics in oncology, immunology, and neurobiology.
  • Served as the COO of a small biotechnology company within Lilly, and participated in all strategic decisions from indications, dosing, to clinical design for a current cutting-edge clinical stage therapy.
  • Led multiple due diligence CMC activities to evaluate several companies throughout my tenure.
  • Started academic collaborations to perform process modelling, and to develop manufacturing technologies like continuous low pH viral inactivation, continuous TFF, and process analytics technologies (PAT).
  • Served as a member of the Science & Technology Council to identify and fund advanced manufacturing technologies.

Director, Process Development & Manufacturing

NanoBio Corporation
08.2014 - 01.2016
  • Responsible for clinical manufacturing activities at contract manufacturing organizations including QuadPharma (now Athenex), CPL, Fraunhofer, and Public Health England.
  • Led gene design, process development, optimization, scale up, formulation, and tech transfer operations for several protein antigens internally and at contract research organizations like Paragon (now Catalent), and Genscript.
  • Authored and was awarded an NIH/NIAID SBIR grants to secure funding for HSV-2 vaccine clinical manufacturing.

Manager, Manufacturing Sciences & Technology

Bristol-Myers Squibb
11.2012 - 08.2014
  • Led the implementation of the process robustness initiative and continued process verification (CPV) at all BMS biologics sites and received a presidential award for that effort.
  • A member of the Global Manufacturing Sciences & Technology senior leadership team that implemented the best-in-class strategy for process performance qualification (PPQ), process control strategy, and life cycle management.
  • Built the process monitoring group across all biologics to perform process monitoring through SPC and MVDA.
  • Established the process modeling capability to improve output and reduce costs at all biologics commercial sites.
  • Senior Scientist, Manufacturing Sciences and Technology, Feb 2011 – Oct 2012
  • Evaluated a next generation downstream process for a blockbuster biologic, estimated the present net value (+$500MM), and collaborated with multiple leaders to implement.
  • Led several investigations, the implementation of several change controls, corrective and preventative measures, and post marketing commitments.
  • Supported several process performance qualifications and pre-approval inspections through determining the strategy and approving the PPQ reports.
  • Supported technology transfers (internally and to CMOs), authored sections of regulatory filings, responded, and coordinated the responses to regulatory questions.

Senior Scientist, Development and Manufacturing

Nabi Biopharmaceuticals
06.2008 - 06.2010
  • Developed and scaled up the upstream and downstream processes including molecular biology and cell bank production, to develop a pentavalent S. aureus vaccine, and then transferred the technology to GlaxoSmithKline.
  • Led all GMP clinical manufacturing activities for phase I.
  • Supported the development and manufacturing activities for a therapeutic enzyme to enhance the value of the program prior to acquisition.

Protein Chemist, Assay Development

Inhibitex Incorporated
06.2005 - 05.2006
  • Company Overview: (a BMS subsidiary since 2012)
  • Investigated regulation of antigen expression on bacterial cells to develop new therapies.
  • Developed assays to support drug substance release testing.

Education

MBA - Management

Cornell University
Ithaca, NY
01.2012

Post-Doctoral Fellowship - Protein Chemistry

Harvard Medical School
Boston, MA
01.2005

Ph.D. - Microbiology (Biochemistry, Molecular and Cellular Biology)

University of Oklahoma
Norman, OK
01.2002

B.S. - Biology

University of Jordan
01.1997

Skills

  • Organizational strategy development
  • Product Acceleration to Market
  • Production workflow optimization
  • Reorganization and globalization
  • Strategic divestment
  • Change management
  • Program management

Languages

English
Native or Bilingual
Arabic
Native or Bilingual
French
Elementary
Hebrew
Elementary

Awards

Represented Lilly and CSL Behring as a steering committee member of the National Institute for Innovation in Manufacturing of Biopharmaceuticals (NIIMBL) Process Intensification program, 2019-Current., Represented Lilly at the Foundation for the National Institutes of Health (FNIH) for Bespoke Gene Therapies, 2019-2020., Coauthored alongside several industry leaders the n-mAb case study to create a guidance for control strategy, deviation management, process characterization and validation in biologics continuous manufacturing, 2022., Coauthored several peer reviewed publications on next generation manufacturing and contributed to the ICH Q13 Guidance., NIH/NIAID study section reviewer as CMC subject matter expert for developing emerging infectious diseases therapies, 2020., Chaired NIH/NIAID ad hoc panel to award $150 million to companies providing the US government with biologics development and manufacturing, 2015., Bristol-Myers Squibb Operational Excellence Presidential Award for Product Robustness across the Global Manufacturing Supply organization, 2013., National Institute of Health (NIH/NIAID) grant/contract peer reviewer and subject matter expert for biodefense and infectious diseases therapeutics (2006, 2008, 2009, 2010, 2013)., NIH post-doctoral research fellowship, Harvard Medical School, 2002- 2005.

Publications

  • Sphere packing on a quantum computer for chromatography modelling. Hall P., Njoroge I., Campbell C., Thotakura P., Rines R., Omole V., Qadan M. Submitted to Arxiv 2024, Nov. Submitted to Scientific Reports 2025, Jul.
  • Managing integrated continuous bioprocesses in real time: Deviations in product quality. Gromping G., Bosley A., Qadan M., Schiel J., Spasoff A., Valax P., Schaefer G. Biotechnology Progress. 2023, Nov; e3414.
  • N-mAb A Case Study to Support Development and Adoption of Integrated Continuous Bioprocesses for Monoclonal Antibodies. 32 authors including Qadan, M. (chapter lead). NIIMBL publications. 2022, Jun.
  • Yang, Q., Tao, Y., Qadan, M., and Ierapeitritou, M. Process Design and Comparison for Batch and Continuous Manufacturing of Recombinant Adeno-Associated Virus. Journal of Pharmaceutical Innovation. 2022, Apr; 1-12.
  • Erickson, J., Baker J., Barrett S., Brady, C., Brower B., Carbonell, R., Charlebois, T., Coffman, J., Connell-Crowley, L., Coolbough, M., Fallon, M., Fallon, E., Garr, E., Gillespie, E., Hart, R., Haug, A., Nyberg, G., Phillips, M., Pollard, D., Qadan, M., Ramos, I., Rogers, K., Schaefer, G., Walther, J., and Lee, K. End-to-end collaboration to transform biopharmaceutical development and manufacturing. Biotechnol Bioeng. 2021 Jan;1–11.
  • Coffman, J., Brower, M., Connell-Crowley, L., Deldari, S., Farid, S., Horowski, B., Patil, U., Pollard, D., Qadan, M., Rose, S., Schaefer, E., and Shultz, J. A common framework for integrated and continuous biomanufacturing. Biotechnol Bioeng 2021 Apr; 118(4): 1735–1749.
  • Yang, Q., Qadan, M., Ierapeitritou, M. Economic analysis of batch and continuous biopharmaceutical antibody production: a review. J Pharm Innov 2019. 14:1-19
  • Qa’dan, M., Christensen, K., Zhang L., Roberts T., and Collier, R. J. Membrane insertion by anthrax protective antigen in cultured cells. Molecular and Cellular Biology. 2005 Jul 25 (13): 5498-2005.
  • Voth, D., Qa’Dan, M., Hamm, E., Pelfrey, J., and J. D. Ballard. Clostridium lethal toxin is maintained in a multimeric protein complex. Infection and Immunity 2004 Jun 72 (6): 3366-72.
  • Spyres. L.M., Daniel, J. Hensley, A., Qa’Dan, M., Ortiz-Leduc, W., and Jimmy D. Ballard. Mutational analysis of the enzymatic domain of Clostridium difficile toxin B reveals novel inhibitors of the wild-type toxin. Infection and Immunity. 2003 71:3294-3301.
  • Qa’dan, M., Ramsey, M., Daniel, J., Spyres, L., Safiejko-Mroczka, B., Ortiz-Leduc, W., and J.D. Ballard. Clostridium difficile toxin B activates dual caspase-dependent and caspase independent apoptosis in intoxicated cells. Cellular Microbiology 2002 Jul 4 (7):425-34.
  • Qa’dan, M., Spyres, L., and J.D. Ballard. PH enhanced cytopathic effects of Clostridium sordellii lethal toxin. Infection and Immunity 2001 69 (9): 5487-5493.
  • Spyres, L.M., Qa’Dan, M., Meader, A., Tomasek, J.J., Howard, E.W. and J.D. Ballard. Cytosolic delivery and characterization of the TcdB glucosylating domain using a heterologous protein fusion. Infection and Immunity 2001 69(1): 599-601.
  • Qa’Dan, M., Spyres, L. and J.D. Ballard. pH induced conformational changes in Clostridium difficile toxin B. Infection and Immunity Sept 2000 68(5):2470-4.

Timeline

Executive Director, Innovation & Pilot Plants, PPD

CSL Behring
10.2024 - Current

Research Advisor, Biologics Research and Development

Eli Lilly and Company
02.2016 - 01.2021

Director, Process Development & Manufacturing

NanoBio Corporation
08.2014 - 01.2016

Manager, Manufacturing Sciences & Technology

Bristol-Myers Squibb
11.2012 - 08.2014

Senior Scientist, Development and Manufacturing

Nabi Biopharmaceuticals
06.2008 - 06.2010

Protein Chemist, Assay Development

Inhibitex Incorporated
06.2005 - 05.2006

Post-Doctoral Fellowship - Protein Chemistry

Harvard Medical School

Ph.D. - Microbiology (Biochemistry, Molecular and Cellular Biology)

University of Oklahoma

B.S. - Biology

University of Jordan

MBA - Management

Cornell University

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