Tim Hahn's Location
Gaithersburg, Maryland, United States, United States
Tim Hahn's Contact Details
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About Tim Hahn
Passionate, purpose-driven SCIENCE, TECHNOLOGY, MANUFACTURING LEADER and TEAM BUILDER who empowers and mentors staff to deliver results while ensuring they “enjoy the journey.” Scientific agility to adapt to emerging technologies. Operations and Quality expertise to transform an organization from pre-clinical/Phase I to a commercial enterprise. International operating experience in Canada, England, The Netherlands, Sweden, and India. Dedicated to developing leaders and integrating cross-functional teams to align on a common vision and mission. Champion of open communication, diversity, inclusion, and integrity.
Tim Hahn Work Experience Details
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Senior Vice President, Influenza CmcNovavax Inc Apr 2020 - PresentGaithersburg, Maryland, UsReturned to Novavax to contribute to the development and launch of a COVID-19 vaccine.• Within one month, established the basis for a new adjuvant CMO supply chain network in Europe and US.• Within 6 months, initiated and completed technology transfer to increase adjuvant manufacturing capacity 10-fold to billions of doses per year.Beginning October 2020, assumed responsibility for CMC elements of the influenza program including process development, formulation development, analytical development, CMO management, and implementation of new manufacturing and analytical technologies. • Manufactured drug substance and product on time for Influenza/COVID-19 combination Phase I and Phase II clinical studies. • Hired, mentored, and led a development team that improved influenza DS process yields 3-fold. -
Chief Technical OfficerImvax, Inc. Jan 2020 - Mar 2020Philadelphia, Pennsylvania, UsAs CTO, my scope included process & analytical development, supply chain, and manufacturing. Imvax has a supportive Board of Directors, an exceptional CEO, a strong leadership team, and a very promising technology. My sole driver for leaving was a personal commitment to support the COVID vaccine program at Novavax based on 9 years of experience advancing the company's saponin-based adjuvant and protein nanoparticle technologies. -
Senior Vice President, Global Manufacturing Operations; Manufacturing And Process DevelopmentNovavax Inc Jun 2011 - Jan 2020Gaithersburg, Maryland, UsSenior Vice President | Global Manufacturing Operations | 2014-2020Senior Vice President | Manufacturing and Process Development | 2011-2014 Led multiple functional teams including Analytical, Process, and Formulation Development, Supply Chain, Technology Transfer, Manufacturing, MS&T, Quality Control, Facilities, and Engineering. Strong partner to Quality Assurance and Regulatory • Drove process definition, manufacturing, QC testing, and associated systems to meet compliance standards for the manufacture, testing, and release of product for on-time delivery for all clinical trials since 2011 • Innovated with identification and adaption of novel technologies leading to robust and scalable processes• Championed a process development program that delivered an 8-fold increase in batch productivity• Drove facility design, renovations, and validation to meet the quality and timeline requirements that expand manufacturing capacity and enhance the regulatory and compliance position of the facility • Advanced laboratory and manufacturing systems and staff from Phase 1 (50 FTE) to Phase 3 PPQ (150 FTE) • Implemented GMP commercial production-enabling quality systems in preparation for CMC regulatory inspections• Integrated the saponin adjuvant manufacturing operations at our subsidiary in Uppsala, Sweden by driving expansion and renovation to upgrade the QC lab, warehouse, and material/personnel flows and by driving technical solutions for commercial product release • Championed Operational Excellence/Lean/Continuous Improvement principles and mindset to entire staff who completed and documented over 150 Lean projects in 5 years
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Vice President, Vaccine ManufacturingMedimmune Mar 2010 - Feb 2011Gaithersburg, Maryland, UsResponsible for influenza vaccine drug substance manufacturing in Speke, UK, drug product manufacturing in Philadelphia, PA, and supply/schedule coordination in Gaithersburg, MD • Delivered product that met the annual demand for $250M seasonal sales for trivalent flu vaccine, FluMist® • Rebuilt the leadership team at the Philadelphia site to upgrade capabilities to improve quality compliance• Achieved no critical or major observations for regulatory inspections at the Philadelphia site for the 2010 season -
Vice President, Antibody ManufacturingMedimmune Oct 2007 - Feb 2010Gaithersburg, Maryland, UsResponsible for bulk antibody manufacturing in Frederick, MD, drug product manufacturing in Nijmegen, NL, and supply/schedule coordination in Gaithersburg, MD • Delivered product that met the demand for $1B sales of Synagis®, monoclonal for prevention of RSV infection• Reduced 6 months from the demonstration timeline at a $500M new facility (four 15K bioreactors) using a “rolling start-up” strategy where the process was run continuously up through each newly turned-over equipment unit• Achieved zero observations for two FDA inspections at the Frederick site • Restructured the leadership team at the Nijmegen site to upgrade capabilities for the transition from clinical to commercial production
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Senior Director, Manufacturing OperationsMerck Mar 2002 - Sep 2007Rahway, New Jersey, UsEnsured the successful production of viral vaccine drug substance for MMR®II, VARIVAX®, VAQTA®, and Rotateq®• Directed an organization of 100 salary and 300 hourly employees in nine distinct production facilities at one site • Responded to questions at multiple international regulatory inspections leading to the approval of four new vaccines in nine months• One of twelve site leaders who developed the future state vision and strategy for the collective bargaining agreement negotiated in 2007 which led to greater labor grade work assignment flexibility -
Director, Manufacturing Science And TechnologyMerck Nov 1998 - Feb 2002Rahway, New Jersey, UsManaged a staff of 30 scientists and engineers who provided technical support for vaccine drug substance produced by cell culture-based and fermentation-based processes • Resolved several critical broad-based, multi-departmental investigations of atypical process performance events leading to the release of critical supplies of sterile pharmaceutical and vaccine products• Led a capital team for a $20M animal care facility project from scope design through start-up to enhance the biosecurity of the chicken flock supplying eggs for the production of MMR®II vaccine• Reduced deviations in Culture Media Manufacturing 95% over 5 years
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Director, Cmo Process Technology TransferMerck Feb 1997 - Oct 1998Rahway, New Jersey, UsDirected a multi-functional team of scientists and engineers from Central Engineering, Process Engineering, Engineering & Technology, Validation, Environmental Monitoring, QC testing, GMP Compliance, and Manufacturing Operations to transfer a process to a contract manufacturing site. Completed the demonstration requirements for the CMO to begin routine production.
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Director, Manufacturing Science And TechnologyMerck Jun 1996 - Jan 1997Rahway, New Jersey, UsLed a group of 10 scientists and engineers responsible for technical coverage in the manufacturing unit, deviation event investigation and resolution, trend investigations, process improvements, manufacturing batch record updates, support for regulatory inspections, and process change implementation.
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Associate Director, Manufacturing Science And TechnologyMerck Feb 1995 - May 1996Rahway, New Jersey, UsLed a group of 6 scientists and engineers responsible for technical coverage in the manufacturing unit, deviation event investigation and resolution, trend investigations, process improvements, manufacturing batch record updates, support for regulatory inspections, and process change implementation.
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Senior Engineer, Manufacturing Science And TechnologyMerck Aug 1994 - Jan 1995Rahway, New Jersey, UsIndividual contributor with responsibility for technical coverage in the manufacturing unit, deviation event investigation and resolution, trend investigations, process improvements, manufacturing batch record updates, and process change implementation.
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Project Engineer, Manufacturing Science And TechnologyMerck Jun 1992 - Jul 1994Rahway, New Jersey, UsIndividual contributor with responsibility for technical coverage in the manufacturing unit, deviation event investigation and resolution, trend investigations, process improvements, manufacturing batch record updates, and process change implementation.
Tim Hahn Skills
Vaccines
Gmp
Technology Transfer
Biotechnology
Manufacturing
Leadership
Management
Process Improvement
Cross Functional Team Leadership
Good Manufacturing Practice
Tim Hahn Education Details
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Stanford UniversityChemical Engineering -
Lehigh UniversityChemical Engineering
Frequently Asked Questions about Tim Hahn
What company does Tim Hahn work for?
Tim Hahn works for Novavax Inc
What is Tim Hahn's role at the current company?
Tim Hahn's current role is Senior Vice President, Technology & CMC.
What is Tim Hahn's email address?
Tim Hahn's email address is ti****@****ast.net
What is Tim Hahn's direct phone number?
Tim Hahn's direct phone number is +124026*****
What schools did Tim Hahn attend?
Tim Hahn attended Stanford University, Lehigh University.
What skills is Tim Hahn known for?
Tim Hahn has skills like Vaccines, Gmp, Technology Transfer, Biotechnology, Manufacturing, Leadership, Management, Process Improvement, Cross Functional Team Leadership, Good Manufacturing Practice.
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