Zack Mcgahey Email and Phone Number
Zack Mcgahey's Location
San Mateo, California, United States, United States
Zack Mcgahey's Contact Details
Zack Mcgahey work email
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Zack Mcgahey personal email
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About Zack Mcgahey
I am a leading executive in operations management, specializing in bioprocess engineering and manufacturing management. I have over 20 years of experience leading manufacturing functions for companies across the pharmaceutical, synthetic biology, diagnostics and automotive industries. I've been a part of multiple operational start-ups at both previous and current employment, and have developed commercial-ready manufacturing operations and staffs at multiple sites.I am currently the Chief Operating Officer for Antheia, Inc, in Menlo Park. In this role, I am responsible for all global manufacturing and quality, as well as regulatory affairs, supply chain, project management, facilities, EH&S and IT. I am responsible for taking Antheia's ground-breaking synthetic biology technology into commercial scale and changing the way essential medicines are made, globally.Before my current role, I oversaw various responsibilities at Zymergen as Vice President of Site Operations and later as Vice President of Manufacturing and Capex Engineering. Before joining Zymergen, I was the Director of Manufacturing Facilities at Tesla, helping accelerate the worlds transition to sustainable energy by building and maintaining the manufacturing facilities for the company out of Fremont. Zack oversaw all design, construction, and facilities operations for 10 Million square feet of factory, warehouse, lab and office.Previously, I was the Head of Manufacturing at Grifols Diagnostic Solutions, responsible for all manufacturing and support operations for the Emeryville (Immunodiagnostics) and San Diego (Nucleic Acids Testing) campuses (~240 people). In this role, I was responsible for all commercial production activities for Grifols’ diagnostic portfolio, as well as warehouse operations, tech transfer, validation, and maintenance/calibration. Before assuming this role, I oversaw Project Horizon, a $100M project to develop a modern, consolidated manufacturing facility in Emeryville for production of all immunodiagnostic products.I have a BS in Bioengineering from UC Berkeley and an MBA from the Wharton School of Business, University of Pennsylvania.
Zack Mcgahey's Current Company Details
Zack Mcgahey Work Experience Details
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Chief Operating OfficerAntheia, Inc. Nov 2021 - PresentMenlo Park, California, UsChief Operating Officer role responsible for all manufacturing, quality, regulatory, engineering, supply chain, project management, facilities, EH&S and IT for the company
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Advisory Board MemberCalifornia Biomanufacturing Center May 2022 - PresentVacaville, California, Us -
Scientific Advisory Board MemberBiop2P Network Oct 2022 - PresentVacaville, California, Us -
Advisory Board MemberNovoloop May 2021 - Sep 2024Menlo Park, Ca, Us -
Advisory Board MemberScifi Foods Mar 2022 - May 2024 -
Vice President, Manufacturing And Capex EngineeringZymergen, Inc. Jun 2021 - Nov 2021Emeryville, California, Us -
Vp Of Site OperationsZymergen, Inc. May 2020 - Jun 2021Emeryville, California, UsResponsible for global real estate, facilities engineering and capital projects, as well as EH&S, Lab Operations, and Product Quality
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Vice President Real Estate, Capital Projects, Eh&SZymergen, Inc. Mar 2019 - May 2020Emeryville, California, UsI currently head up all site development and capital projects, facilites engineering and EH&S at Zymergen, a science and innovation company focusing on partnering with nature to be the catalyst of the next industrial revolution. Our departments service a rapidly expanding portfolio of locations and over 800 employees, including the devlelopment of a new 300,000 square foot headquarters / research facility in Emeryville.
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Director Of Manufacturing FacilitiesTesla Jan 2018 - Mar 2019Austin, Texas, UsAs Director of Manufacturing Facilities, I was responsible for all design, construction, and operations of a network of 18 buildings servicing the automotive business located primarily in Northern California. Working out of Fremont, I managed teams responsible for production facilities including the Fremont factory, as well as the Lathrop manufacturing facility, Livermore supply chain buildings, and Tesla Grand Rapids tool making facility. We also support facility operations for additional buildings in Palo Alto, Newark, Hayward, San Jose and Sunnyvale.Of primary importance in this role, my team managed all infrastructure development and operations support for the Tesla Fremont factories, where we manufacture all Model S, Model X, and Model 3 cars. The factory has 5 million square feet under roof and operated 24/7. We operate as a stand-alone EPC function, capable of developing and stamping our engineering designs, submitting them to city officials, and self performing construction work for facilities in constant state of growth and change. -
Senior Director / Head Of ManufacturingGrifols May 2015 - Jan 2018Sant Cugat Del Vallès, Barcelona, EsHead of Manufacturing at Grifols Diagnostic Solutions in Emeryvillle, CA and San Diego, CA. In this role, I was responsible for the production of all immunodiagnostic products in Emeryville for 21 different commercial products (multiple licensed), as well as all Nucleic Acid Testing (NAT) products in San Diego. I am responsible for and oversee production teams in microbial fermentation, purification / conjugation, oligonucleotide synthesis, compounding, bulk / large volume fill, and tech services. I also oversaw warehouse operations, manufacturing support (tech transfer), validation (projects, process, cleaning), continuous process verification (CPV), and all campus calibration and maintenance services. This includes managing multiple cost centers (over $60MM in annual budget) and the direct and indirect management of over 240 people in 2 locations between Emeryville and San Diego.In addition, Grifols built a consolidated manufacturing facility for all immunodiagnostic production, and I led the manufacturing efforts to assist and resource the project team (Project Horizon) in starting up this new manufacturing facility and transferring all processes and staff into the new building by 2018. -
Head, Project Horizon OperationsGrifols Aug 2014 - May 2015Sant Cugat Del Vallès, Barcelona, EsPrimary responsibilities include the development of operational capabilities for a new manufacturing building (CMF) to consolidate all immunodiagnostic manufacturing processes into a single facility. Responsible for driving all critical activities from equipment C&Q all the way though tech transfer and final process validation for 21 products (multiple licensed) Align operational needs with key stakeholders through detailed design engineering, construction, commissioning, qualification, operational ramp-up (engineering runs), tech transfer and process / cleaning validation. Develop resource needs to support all facility, GMP warehouse, and manufacturing operations through the project and manage/oversee integration of project resources from global departments.
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Associate Director Of ManufacturingRevance Therapeutics Jan 2013 - Aug 2014Nashville, Tennessee, UsPrimary responsibilities include the oversight of the manufacturing facility retrofit to increase drug product scale for commercial manufacturing capacity, including the design engineering and installation of a 13-unit commercial fill line with two commercial freeze driers and automated inspection. Work with facilities, engineering teams, general contractors and subs to adapt facility to support commercial manufacturing equipment, from Basis of Design and MEP detailed engineering all the way through machine installation. FAT/SAT/start-up and validation.I handle all coordination activities for the project and maintain the entire project map for commercial manufacturing readiness. Responsible for building department staff of manufacturing associates and engineers to start up line and develop commercially robust processes.I also run the materials management department and have participated in the steering committee for ERP deployment. In addition, I oversee all manual and automated visual inspection programs and developed preliminary plans for automated packaging. -
Senior Manager Of ManufacturingRevance Therapeutics Feb 2012 - Feb 2013Nashville, Tennessee, UsOversaw all Purification MFG activities in the plant in Newark, CA. In addition, I was in charge of developing and engineering the scale-up efforts for commercial manufacturing, including a 7-unit fill line with two commercial lyophilizers.
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Manufacturing ManagerRevance Therapeutics Jan 2010 - Feb 2012Nashville, Tennessee, UsAs Manager of Manufacturing for the Purification, Solution preparation, and Parts Preparation groups at Revance Therapeutics, I manage a team of 4 associates and technicians and work with a Drug-Substance Manufacturing team of 9 in a toxin manufacturing plant (bacterial fermentation). We are a FDA and CDC regulated facility. This facility was built in late 2009 and was brought online in early 2010, currently making GMP-quality material for phase III clinical trials. The facility will be a commercial facility pending successful trials. I helped manage the start-up and commissioning of 2 hollow fiber TFF skids, a scale-up nuclease digestion system, and an AKTA Pilot Chromatography unit. All systems are now validated for use with operational SOPs effective and in place.As a Manager of the manufacturing team, I also participated in all Phase III and GMP-readiness coordination meetings, and developed timelines for implementation and validation of manufacturing equipment and processes.I also head the Process Controls team at Revance therapeutics, and worked to coordinate the installation and validation of an automated Process Data Historian and Batch Reporting System. We use contracted engineering teams for development and installation. I have experience in engineering and working with outside contractors.
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Manager Of ManufacturingFibrogen Jun 2009 - Jan 2010San Francisco, Ca, Us -
Pilot Plant Manufacturing SupervisorFibrogen Jan 2008 - Mar 2009San Francisco, Ca, UsSchedule all Pilot Plant GMP and Process Development activities.Stay actively involved all processing (upstream / downstream / formulation) operations in the Pilot PlantOrder Pilot Plant raw materials, general supplies and equipment to ensure sufficient supply for planned fermentation and DSP batches.Generate and update Standard Operating Procedures and Manufacturing Procedures for GMP activities.Review and correct completed Manufacturing Procedures prior to submittal to Quality Assurance.Manage activities/review annual performances of 3 Engineers and 2 Technicians.Develop training management system (with Documentum) and ensure that employee training records are kept updated for PP GMP batch activities.Assign Lot numbers and finance related Production codes for all GMP Pilot Plant related activities.Track general tasks and batches related to operations of the Process Development labs.Generate Pilot Plant activity monthly reports.Lead the hiring process for new members of the Pilot Plant team (as required).Ensure that Pilot Plant is maintained in a manner suitable for inspection, audits and third party tours. Conduct planned audits of the Facility operations per the Quality Assurance Department schedule and ensures that audits findings are addressed in a timely manner.Manage/Co-ordinate effective calibration, PM and repair operations related to Pilot Plant GMP operations while adhering to Change Control guidance.Manage all Deviation Reports and Corrective Actions generated from Pilot Plant operations.
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Fermentation Engineer/ScientistFibrogen May 2006 - Jan 2008San Francisco, Ca, UsPerform in a wide variety of roles with FibroGen as a process engineer, process development associate, and GMP cell culture and engineering advisor/auditor for contract manufacturers and research groups. Participate in 400L GMP yeast fermentation (Pichia Pastoris) campaigns for a variety of proteins.Build a small onsite cell culture Process development laboratory, including the sourcing of all materials and equipment, routing of utility lines, and set up of small-scale process reactors.Work with Process Development to run scale down fermentations (Pichia) and MAB Cell Culture (CHO) for tech transfer to Contract manufacturers.Collaborate with Facilities and Process development on the design of a new Pilot Plant and Process Development laboratory in Mission Bay. This includes sourcing of equipment, working with building designers to scale utility requirements for the facility, and reviewing all GMP layout designs.Assist troubleshooting of systems and processes with contract manufacturers (travel required) and provide feedback to Contract Manufacturing Committee when required. Perform engineering evaluations and functions in the Pilot Plant as processes and systems are found to be sub-optimal.; Assist MFG supervisor in coordinating efforts on the cGMP Manufacturing plant floorSchedule daily operations, and facilitate group meetings in the mornings and afternoons.Participate in annual performance review process and assist in authoring of performance evaluations. Work with associates to assist them in their careers / trainingAssist Manufacturing supervisors in evaluating hours for production for annual labor cost analysisScreen resumes and perform initial phone interviews for potential candidate screening and participate in follow-up candidate interviews for manufacturing operators and supervisors.
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Manufacturing LeadCell Genesys 2005 - 2006Hayward, Ca, Us -
Manufacturing AssociateCell Genesys Jul 2002 - Jun 2005Hayward, Ca, UsPerform daily cell culture responsibilities including, but not limited to, Bench top seed-train mammalian cell cultures up to 50L perfusion bioreactorsCIP and SIP of 50L, 400L, and 3500L stainless hold vessels and bioreactorsMedia and buffer preparationFinal product processing and fillingAssisted in start-up of CIP skids, processing vessels and equipment, including execution of validation IQ, OQ and PQ protocols.Wrote and edited numerous SOPs and production records, deviation reports, process change requests and equipment change requests.Assisted in start-up and troubleshooting of large-scale fill line, specializing in vial labeling.Coordinated all final product irradiation scheduling and activities. All activities were ongoing during the start up of a new phase III/commercial production facility
Zack Mcgahey Skills
Gmp
Validation
Technology Transfer
Biotechnology
Sop
Pharmaceutical Industry
Purification
Change Control
Quality Assurance
Biopharmaceuticals
Manufacturing
Clinical Trials
Chromatography
Process Simulation
Lifesciences
Medical Devices
Cell Culture
Process Engineering
Hplc
Capa
Quality System
Life Sciences
Fermentation
Process Validation
Protein Chemistry
Aseptic Technique
Glp
Laboratory
Formulation
21 Cfr Part 11
Downstream Processing
Aseptic Processing
Equipment Design
Small Business
Filtration
Molecular Biology
Protein Purification
Fermentation Technology
Zack Mcgahey Education Details
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University Of California, BerkeleyBioengineering -
The Wharton SchoolManagement
Frequently Asked Questions about Zack Mcgahey
What company does Zack Mcgahey work for?
Zack Mcgahey works for Antheia, Inc.
What is Zack Mcgahey's role at the current company?
Zack Mcgahey's current role is Executive in Manufacturing, Engineering, and Operations management.
What is Zack Mcgahey's email address?
Zack Mcgahey's email address is za****@****gen.com
What schools did Zack Mcgahey attend?
Zack Mcgahey attended University Of California, Berkeley, The Wharton School.
What skills is Zack Mcgahey known for?
Zack Mcgahey has skills like Gmp, Validation, Technology Transfer, Biotechnology, Sop, Pharmaceutical Industry, Purification, Change Control, Quality Assurance, Biopharmaceuticals, Manufacturing, Clinical Trials.
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