Frank Bourbon Email & Phone Number

Kissimmee, FL, US

Pointe-Claire, Quebec, CA

Quality Management System Roll-out in Medical Devices and OTC worldwide environment

Senior Quality Expert and Advisor in Pharmaceutical Industry

Supplier Program Management

San Francisco, California, US

Advising, mentoring, and managing a dynamic biotech’s Quality Team for their upcoming FDA pre-approval inspection

Reggello, FI, IT

Quality Project Management, Advisor and Audit Program

Saint Genis Pouilly, FR

Reviewing, coaching, mentoring in a RadioPharmaceutical environment. Specific focus on Deviation, OOS, CC, CAPA and Trainings.

Western Springs, Illinois, US

Lead the Technical & Quality Transfer of Cell Therapeutic products and LAL devices.Site audits and Quality Assessments - Quality Strategies - Tech Transfer

Zug, CH

Lead 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

San Francisco, CA, US

As 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.

San Francisco, CA, US

QA 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

San Francisco, CA, US

Responsible 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.

San Francisco, CA, US

Evaluation 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.

San Francisco, CA, US

Evaluation 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.

San Francisco, CA, US

Evaluation 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.

Paris, France, FR

Associate 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 &.

Paris, France, FR

Leader 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.

Paris, France, FR

Manager 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.

Paris, France, FR

Coordinator 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.

Paris, France, FR

Responsible 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.

Rahway, New Jersey, US

Manager 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.