Jamie Martin
Director, Product Quality Lead @Vertex Pharmaceuticals
Signup · Get unlimited contacts
WORK HISTORY
Director, Product Quality Lead @Vertex Pharmaceuticals
EDUCATION
Southern New Hampshire University
Master of Business Administration - MBA
US Navy, Naval Nuclear Propulsion Program
Completed Certification as Nuclear Mechanical Operator
University of New England
Bachelor's degree
ABOUT JAMIE MARTIN
Experienced and passionate process/program management leader with 20 years of experience in the pharmaceutical, medical device and combination product sectors. Career milestones include, but are not limited to:Senior program manager leading a team of 40+ engineers and scientists responsible for the design and build of multiple fully automated, pilot and commercial scale aseptic filling systems. Systems designed to fill, inspect, test, package and label combination product (cell therapy + surgical implantable device) in support of T1D clinical trials. Required management of complex supplier network across US, EU and Asia.Cross functional team leader responsible for commissioning of new/retrofit biopharmaceutical MFG facility and process transfer/performance qualification of a commercial MFG process. Project duration: 2 yrs; total contract value:$230MM; overall MFG process yield/throughput: 97%. Led MFG line transfer for portfolio of 6 electrosurgical medical devices from internal MFG asset to external supplier including ownership of RFP/supplier selection, contract negotiations, creation of capex budget, new MFG line qualification/validation and release for commercial production. Project duration: 18 mos; portfolio value:$125mm; MFG cost reduction after transfer: 30%. Head of PMO function for phase combination medical device/biopharmaceutical product including selection/implementation of electronic QMS for GXP documentation of drug and device development; creation and execution of complex MS project plans for PMA (pre-market approval) and NDA (new drug application) regulatory submissions. Project duration: 18 mos; plan presentation at FDA pre-meeting resulted in fast-track designation.Skills include:Contract NegotiationsProject ManagementPortfolio ManagementProduct DevelopmentContract Management RFP/SOWCross functional leadershipMS Project / Project PlansChange ManagementFMEA / Risk ManagementChromatographyRegulatory Submissions (PMA, IND, NDA, 510k, BLA)Budget CreationFinancial ModelingResource ManagementLean ManagementQuality Systems ManagementProcess ImprovementGXPEngineering/Mechanical SystemsUF/DF, TFF, VRFClinical Trial ManagementResearch and DevelopmentCMC ManagementSupplier ManagementValidationProtein PurificationCommercial ContractsRCA, CAPAControls / AutomationCpk, control charting
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.