Timothy Coyle's Location
Boston, Massachusetts, United States, United States
Timothy Coyle's Contact Details
Timothy Coyle work email
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Timothy Coyle phone numbers
About Timothy Coyle
Dynamic leader with extensive experience in operations management, particularly in the CHO, mRNA and pDNA manufacture. Proven track record in overseeing large-scale production processes, managing multi-million dollar budgets, and driving innovation in manufacturing. Skilled in regulatory compliance, talent development, process optimization, technology development and cross-functional collaboration. Highly successful managing large teams and complex projects within fast-paced environments, driving innovation and efficiency in biopharmaceutical production.
Timothy Coyle's Current Company Details
Nextgen Biotech Consulting
Founder and Principal
Boston, MA, US
Timothy Coyle Work Experience Details
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Founder And PrincipalNextgen Biotech ConsultingBoston, Ma, Us
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Director Of Manufacturing OperationsPfizer Dec 2021 - Jun 2023New York, New York, UsDirector COVID-19 pDNA/mRNA Drug Substance Production and pDNA for use in pAAV Gene Therapy programs. Overall leadership of Operations functions essential for Clinical & Commercial plasmid DNA, mRNA and COVID-19 drug substance.Dynamic leader with extensive experience in operations management, particularly in the biotechnology sector. Proven track record in overseeing large-scale production processes, managing multi-million dollar budgets, and driving innovation in manufacturing. Skilled in regulatory compliance, talent development, and cross-functional collaboration.Direct leadership for the manufacturing organization in multiple production lines with accountability for the matrix cross functional leadership team (Production Readiness to Product Release). -
Associate Director Of Manufacturing OperationsPfizer Oct 2019 - Oct 2022New York, New York, UsAssociate Director of plasmid DNA production for Gene Therapy (pAAV) and COVID-19 DNA mRNA Production. Results-driven operations leader with a strong background in biotechnology and pharmaceutical manufacturing. Proven expertise in leading large-scale projects, driving innovation, and achieving regulatory compliance. Experienced in team development, process optimization, and cross-functional collaboration.
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Program Lead, New Technology DevelopmentPfizer Mar 2016 - Oct 2019New York, New York, UsOversaw site technology roadmap development and governance for all Pfizer Biotech sited globally. Established a processes for ideation, review, prioritization, testing, and cGMP implementation of new technologies, and also created and maintained a pipeline of future projects.Innovative biotechnology leader with extensive experience in technology development and process optimization. Proven ability to drive transformative projects, enhance production capabilities, and implement cutting-edge technologies. Skilled in cross-functional collaboration, strategic planning, and regulatory compliance.
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Multi-Product Operations Readiness LeadPfizer Jan 2015 - Apr 2016New York, New York, UsManaged the delivery of a critical €150M facility expansion project including automation, equipment commissioning and validation, tech transfer, analytical method qualification and new material introduction.Utilized my extensive experience in project management and facility expansion within the biotechnology sector. Leveraged expertise and track record in overseeing multi-million dollar projects, optimizing production processes, and implementing best practices for new product introduction. Role required skilled team leadership, technical oversight, and knowledge of regulatory compliance.
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Senior Technical ManagerPfizer Aug 2012 - Jan 2015New York, New York, UsManaged a team of Scientists and Engineers in the commercialization of CHO derived biologics with areas of focus including process technical transfers, process validation, at-scale process development, technical investigations, BoH inspection and process change control. Functioned as a results-oriented biotechnology leader with applying my expertise in biologics process development, regulatory compliance, and technical transfer. Leveraged my proven success in leading cross-functional teams, optimizing production processes, and navigating complex regulatory landscapes. Strong track record in managing inspections and audits, ensuring quality standards, and driving innovation in biologics manufacturing.
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Manufacturing Operations ManagerPfizer Jul 2011 - Jul 2012New York, New York, UsManaged and led a team of process technicians, scientists, and engineers in the production of clinical and commercial CHO-derived biologics and provided oversight of all aspects of media and buffer formulation, as well as upstream and downstream operations. Functioned as a highly successful and results-driven biotechnology leader with expertise in managing operations in a fast paced and rapidly changing simultaneous multi product environment. Leveraged my proven track record in process optimization, team leadership, and implementing continuous improvement methodologies to enhance productivity and yield. Adept at mentoring teams and driving financial impact through strategic process enhancements.
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Scientist IiPfizer Aug 2010 - Jul 2011New York, New York, UsExperienced biotechnology Scientist with a strong background in technical transfers, process validation, and operational efficiency. Proven ability to lead complex projects involving the relocation and modernization of manufacturing processes, ensuring compliance with regulatory standards and enhancing safety and reliability.Mammalian Cell Culture and Protein Purification process execution and development, scale up and system design.
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Scientist IWyeth Biopharma Jan 2006 - Aug 2010Served as lead upstream scientist in a multiproduct facility in CHO cell culture operations for both commercial and clinical products.Highly successful upstream scientist with extensive experience in CHO cell culture operations within multi-product facilities. Proven expertise in process execution, technology transfer, real-time data analysis, and operational coordination for commercial and clinical biologics. Committed to ensuring process robustness and timely supply of drug substances. -
Associate ScientistWyeth Biopharma Jan 2005 - Jul 2006Provided leadership in the technology transfer of clinical candidates from development to large-scale production. Led in the preparation and development of SOP’s and other pertinent documents followed by personnel. Prepared experimental protocols, data analysis, data summaries and technical reports. Daily preparation of Buffer, Media and Bioreactor Formulations and relevant analytics of those solutions and support of upstream and downstream operations. Adept at managing cleaning processes, developing SOPs, and conducting data analysis for process optimization.
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Senior Process TechnicianWyeth Biopharma Jun 2002 - Jan 2005Executed facility Startup of a multi-product bioprocess facility with a focus on CIP system IQ, OQ, PQ.Member of the team to receive the first ever FDA licensure to operate a simultaneous multi-product biologics facility.Served as a leader in the execution of operations supporting the culture of CHO cell culture and subsequent purification while adhering to GMP’s. Provided leadership in the technology transfer of clinical candidates from development to large-scale production.Executed cleaning and sterilization of equipment both manually and through PLC driven automated systems. Lead in the preparation and development of SOP’s and other pertinent documents followed by personnel.Prepared experimental protocols, data analysis, data summaries and technical reports.Performed biological growth and aseptic processes while maintaining constant sterilization for the production of commercial and clinical products. Daily preparation of Buffer, Media and Bioreactor Formulations and relevant analytics of those solutions.
Timothy Coyle Skills
Cell Culture
Gmp
Biotechnology
Protein Purification
Drug Development
Validation
Pharmaceutical Industry
Sop
Fda
Technology Transfer
Timothy Coyle Education Details
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The George Washington UniversityGeneral -
The George Washington UniversityBiology
Frequently Asked Questions about Timothy Coyle
What company does Timothy Coyle work for?
Timothy Coyle works for Nextgen Biotech Consulting
What is Timothy Coyle's role at the current company?
Timothy Coyle's current role is Founder and Principal.
What is Timothy Coyle's email address?
Timothy Coyle's email address is tc****@****eth.com
What is Timothy Coyle's direct phone number?
Timothy Coyle's direct phone number is +121257*****
What schools did Timothy Coyle attend?
Timothy Coyle attended The George Washington University, The George Washington University.
What skills is Timothy Coyle known for?
Timothy Coyle has skills like Cell Culture, Gmp, Biotechnology, Protein Purification, Drug Development, Validation, Pharmaceutical Industry, Sop, Fda, Technology Transfer.
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