Frank Bourbon Email and Phone Number
Kissimmee, FL, US
Frank Bourbon's Location
Kissimmee, Florida, United States, United States
Frank Bourbon's Contact Details
Frank Bourbon work email
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Frank Bourbon personal email
n/a
About Frank Bourbon
Senior expert with 28 years of hands-on experience in Pharma, Biotech, Medical Device, Radiopharma, Cell Therapy, including 16 years with leading global healthcare companies focusing on Quality Assurance, GMP Manufacturing and Development, and 12 years in Quality Consulting. Seeking remote contracts to support US and international Quality teams.English: bilingualFrench: mother languageSpanish: Intermediate
Frank Bourbon's Current Company Details
Frank Bourbon Work Experience Details
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Principal OwnerBourbon Quality Consulting, LlcKissimmee, Fl, Us
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Head Qms SupportLesirg Consultants Jul 2023 - PresentPointe-Claire, Quebec, CaQuality Management System Roll-out in Medical Devices and OTC worldwide environment
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OwnerBqc Advisory Llc Aug 2016 - PresentSenior Quality Expert and Advisor in Pharmaceutical Industry
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Supplier Program Management/ConsultingBlackdiamondnet Jul 2021 - Jun 2023Supplier Program Management
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Quality Project ManagerExemplar Compliance Mar 2022 - Dec 2022San Francisco, California, UsAdvising, mentoring, and managing a dynamic biotech’s Quality Team for their upcoming FDA pre-approval inspection -
Quality ConsultantPqe Group Apr 2020 - Feb 2022Reggello, Fi, ItQuality Project Management, Advisor and Audit Program -
Quality AdvisorAdvanced Accelerator Applications Sep 2019 - Apr 2020Saint Genis Pouilly, FrReviewing, coaching, mentoring in a RadioPharmaceutical environment. Specific focus on Deviation, OOS, CC, CAPA and Trainings. -
Tech Transfer Quality Consultant - Cell Therapy And LalTreximo Oct 2017 - Apr 2019Western Springs, Illinois, UsLead the Technical & Quality Transfer of Cell Therapeutic products and LAL devices.Site audits and Quality Assessments - Quality Strategies - Tech Transfer -
Quality Project ManagerGenioo Aug 2016 - May 2017Zug, ChLead the Technical & Quality Transfer of Car-T cell therapeutic products from a Biotech in Canada to CMOs in the US and India.Set up a manufacturing process which is GMP approved by the FDA, for use in human cells. ISO 13485Site audits and Quality Assessments - Quality Strategies - KPIs - Budget - Resources -
Quality Consultant In Pharmaceutical Industry - Production - Bend Research/CapsugelValidant May 2016 - Jul 2016San Francisco, Ca, UsAs QC Manager I support: a) Finished product release testing; b) Finished product stability testing; c) In-process testing; d) Cleaning verification testing; e) Raw material testing; f) Method validation and transfer; g) Perform OOS and deviation investigations and prepare reports; h) Manage all activities to ensure all timelines are met and all work meets cGMP standards.Proved ability to manage a large team under remediation environment -
Quality Consultant In Pharmaceutical Industry - R&D - GileadValidant Apr 2015 - Apr 2016San Francisco, Ca, UsQA Validation reviewer: Reviews of current and up coming method validation, protocols/data and current method validation SOP requirements. This will include Drug Substance, Drug Product and Raw Material analytical methods.Demonstrated coordination skills to improve relationships between QA and Analytical departments
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Quality Consultant In Pharmaceutical Industry - Production - Fresenius Medical CareValidant Jun 2014 - Dec 2014San Francisco, Ca, UsResponsible for evaluation of previous changes made under the existing change management process (Manufacture of dialysis products for patients with chronic kidney disease).Recommendations to prioritize the deliverables based on regulatory compliance and patient risk.Proved ability to evaluate the implemented Quality System in a thourough review.
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Quality Consultant In Pharmaceutical Industry - R&D - Impax LaboratoriesValidant Jun 2013 - Jun 2014San Francisco, Ca, UsEvaluation and assessment of R&D analytical methods - Remediation Plan Writing Analytical Protocols/Reports for Method Validation to complete Abbreviated New Drug Applications (ANDA). Participation to the Analytical Transfers with the Taiwan site. Proved ability to work at high-speed within a multi-projects environment.
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Quality Consultant In Pharmaceutical Industry - Generics Production - Impax LaboratoriesValidant Apr 2013 - Jun 2013San Francisco, Ca, UsEvaluation and assessment of QC analytical methods - Enhancement Project Plan 200 assessments written by the consultant team, reviewed and submitted to QA for approval. Proved ability to respect aggressive timelines.
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Quality Consultant In Pharmaceutical Industry - Generics & Aseptic Production - SandozValidant Apr 2012 - Apr 2013San Francisco, Ca, UsEvaluation of deviations, complaints, OOS and investigations processes related to the production of all Product batches produced at the facility. Facility manufactures Generics in an Aseptic Production – Remediation Environment. Assessment of writers, reviewers and approvers of deviations and investigations to determine their level of skill and the necessity for certification training. 24 people certified by Dec. 2012 with a mentoring / training program. Compliance evaluation of all cGMP activities related to Quality Control operations for the analytical chemistry laboratory. Experience with influencing at various levels in organization: operational to Leadership team level. Proved ability to work independently with minimal supervision.
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Sites Quality Operations - Associate DirectorSanofi-Aventis Jan 2010 - Apr 2012Paris, France, FrAssociate Director for US Sites Quality Operations – Multi sites (NJ, PA, MA) – Part of a group of 50 people – up to 7 direct reports. Responsible for all electronic Quality Systems implemented within US SQO. Administrator for LIMS, Inventory, documentation, resources, Trackwise®. Leader for implementation of investigation, Deviation, OOS, change control & CAPA.Root cause investigation tools and training/mentoring employees. GMP Audits schedule – Working Groups as active membership: Intranet, Communication, Metrics, Workflow, eTool and Approval Suppliers – Training plan coordinator – Self-inspection coordinator – Archiving team member (OmniRIM training) QC release responsible for Packaging Operations. Proved ability to lead Global assignments within multi-cultures Environment. -
Quality Unit DirectionSanofi-Aventis Apr 2008 - Jan 2010Paris, France, FrLeader of Quality Assurance and Head of Quality Control of sanofi Bridgewater, NJ. Management of 22 people - Implementation of a new organization to find synergy for better efficiency – Control Quality Systems (CAPA/Deviation/OOS/LIMS) - Communication with other R&D departments (presentations & audits) - European certification maintenance - Expertise in solutions and trainings – Budgets supervising (equipment, chemical, travel) - QU Team careers improvement management. QC release responsible for Drug Substances and for Drug Product manufactures. Proved ability to manage an entire local Quality Department
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Quality Control ManagerSanofi-Aventis Jul 2007 - Mar 2008Paris, France, FrManager of the receptions, analyses and releases of excipients, drug substances and drug products used and/or manufactured in R&D, in accordance with GMP procedures – Involved in the EMEA inspection of the site – Certification in July 2007 – Bridgewater, NJDemonstrated expertise within Quality Control Department.
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Chemistry Manufacture Control CoordinatorSanofi-Aventis Jul 2006 - Jun 2007Paris, France, FrCoordinator of the CMC activities for sanofi Projects (oligonucleotide – sterile liquid associated with an inhalation device) - Organization of monthly face-to-face meetings with other CMC departments involved in these projects – Key member of the Project Review Meeting organized in collaboration with Safety, Clinical and Regulatory departments to respect planning.Proved adaptability with different cultures within Pharmaceutical Industry.
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Responsible Of Mass Spectrometry LaboratorySanofi-Aventis Mar 1998 - Jun 2006Paris, France, FrResponsible of Mass Spectrometry Laboratory for 7 years - Support to the Chemical Development & Quality Control departments - Involvement with blockbuster products Plavix® & Multaq® and Oligosaccharide sterile injectable compounds - Laboratory reports integration in FDA and EMEA regulatory documentation - In charge of the laboratory quality documentation.Proved ability to be recognized as an expert about Mass Spectrometry.
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Quality Control Director AssistantMerck-Lipha Jan 1996 - Jan 1997Rahway, New Jersey, UsManager of 14 Laboratory Analysts - Drug substances and drug products analyses and verification - Laboratory agenda planning. Developer and writer for Merck’s Pentoxyfilline® 400mg generic analytical dossier - Approval by the French Regulatory Authorities in September 1997. Demonstrated rapid adaptability to a new Environment.
Frank Bourbon Skills
Gmp
Pharmaceutical Industry
Fda
Capa
Sop
Quality Assurance
Change Control
Quality Control
Chemistry
Quality System
Teamwork
Glp
R&d
Biotechnology
Gxp
21 Cfr Part 11
Drug Development
Analytical Chemistry
Biopharmaceuticals
Technology Transfer
Laboratory
Multitasker
Coaching
Mentoring
Team Player
Manufacturing
Aseptic Processing
Corrective And Preventive Action
Facilitator
Integrity
Fairness
Curiosity
Software Documentation
Frank Bourbon Education Details
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Ismra Engineer College - Caen – FranceAnalytical Chemistry
Frequently Asked Questions about Frank Bourbon
What company does Frank Bourbon work for?
Frank Bourbon works for Bourbon Quality Consulting, Llc
What is Frank Bourbon's role at the current company?
Frank Bourbon's current role is Principal Owner.
What is Frank Bourbon's email address?
Frank Bourbon's email address is b.****@****oup.com
What schools did Frank Bourbon attend?
Frank Bourbon attended Ismra Engineer College - Caen – France.
What skills is Frank Bourbon known for?
Frank Bourbon has skills like Gmp, Pharmaceutical Industry, Fda, Capa, Sop, Quality Assurance, Change Control, Quality Control, Chemistry, Quality System, Teamwork, Glp.
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