Jason Vines Email & Phone Number

Folkestone, England, Gb

Boston, Ma, Us

• Conducted project planning for design and construction of a new GMP pharmaceutical manufacturing and laboratory facility. • Established the qualification effort for a manufacturing facility which was used to produce medical device supplies used in phase I/II trials. • Took ownership facility management department which ensured compliance with all county and state regulations. • Led the effort to obtain a DEA controlled substance manufacturing license and ensured compliance in all DEA audits. • Designed benchtop mechanical equipment modifications using Solidworks design software. • Prepared and modified manufacturing and general facility floorplans using AutoCAD. • Managed the preventative maintenance and upgrades for the 25000 square foot laboratory and manufacturing facility. • Led a manufacturing engineering team that developed repeatable, cost effective and scalable processes for advanced drug delivery systems. • Prepared the company for a GMP phase 2 manufacturing run by planning a qualification plan for combination drug delivery device processing equipment. • Worked cooperatively with the Quality Assurance department to ensure all of the necessary procedures, specifications, and documentation was in place for a GMP facility. • Instituted a new EH&S training program for the company which greatly improved compliance and understanding of safety procedures for a chemical laboratory environment. • Participated in senior management meetings which have led to a positive working environment and culture. • Led a team which developed many process development reports which were used to establish critical process parameters for the MicroCor Drug Delivery systems. • Continued to supervise all operational activities which include IT, material management, EH&S, Cal/PM, and facilities

Boston, Ma, Us

• Certified Microsoft Azure and Office 365 administrator. • Supervised offsite helpdesk service implementation and ongoing IT operations. • Led a team which transitioned server farm to virtual environment which saved costs and ensured minimal downtime. • Developed a disaster recovery plan utilizing Veam and remote backup technology. • Implemented single sign on features for HR, ERP, Lab Information, Building Management, Building Security software. • Programmed an ASP based sharepoint web application and implemented forms authentication which was used to collaborate on documents with an outside consulting firm. • Designed a Materials Inventory control application using SQL server and Microsoft IIS. • Authored all FDA compliant SOPs for computer system administration. • Designed and maintained a Microsoft Windows Network including 80+ workstations and over 50 users. • Setup a secure VPN connection between a branch office and mobile users. • Managed a LAN using 3com and Cisco switches configured for Voice over IP. • Deployed a secure wireless solution for the LAN. • Implemented Windows Deployment Services for easy desktop deployment. • Setup and maintained the Microsoft exchange corporate email server. • Managed and configured Perkin Elmer, Agilent, and Waters software and equipment for use in a networked environment. • Developed a data backup plan to assure all legal and operational integrity. • Troubleshot computer controlled scientific equipment leading to almost no downtime.

Boston, Ma, Us

• Supervised a manufacturing engineering team that developed repeatable, cost effective and scalable processes for advanced drug delivery systems.• Led the training program for manufacturing technicians and operators.• Mentored junior scientists on career development, establishing new technical skills, and cross functional project work.• Lead the development of a higher throughput manufacturing system that can be used to produce phase 1 GMP products.• Successfully implemented a 5S corporate philosophy for organizing the labs, warehouse, and manufacturing areas.• Authored process flow charts, manufacturing layouts and implemented them into practice on multiple projects.• Continued to supervise all operational activities which include IT, material management, EH&S, Cal/PM, and facilities.

Boston, Ma, Us

• Led a team that produced advanced drug delivery systems for multiple partner feasibility studies.• Supervised operational activities which included materials managemet, calibration and preventative maintenance, and facilities.• Established a successful cross functional problem solving strategy for continuous manufacturing and process improvement.• Implemented a scalable UV curing process and a pressure sensitive adhesive lamination process which solved multiple problems with production of microstructure arrays.• Authored a custom CAL/PM internal web application and successfully implemented it into regular practice.

Boston, Ma, Us

• Modified GXP compliant manufacturing equipment through engineering design controls to optimize processing parameters. • Authored equipment specifications for use in GXP production of state of the art transdermal systems.• Managed and programmed Siemens HVAC building PID control system to maintain sensitive clean room environmental conditions.

Boston, Ma, Us

• Developed adhesive coating process parameters through documented experiments for the production transdermal systems.• Performed physical testing on pharmaceutical materials used in clinical trials in a FDA regulated environment.• Diagnosed electro-mechanical problems on processing equipment which significantly reduced downtime. • Identified and procured cost effective extrusion equipment to solve complex processing problems.• Designed fixtures for use on physical testing equipment using SolidWorks design software.• Authored SOPs and trained scientists on the proper use of adhesive coating equipment which helped in the development of transdermal systems. • Developed an inventory control system for controlled substances to comply with the DEA Code of Federal Regulations.• Managed disposal and procurement of controlled substances for a DEA regulated facility.• Authored SOPs and trained employees on controlled substance handling procedures.• Served as the safety committee member for the Product Development department.

Boston, Ma, Us

• Expert in physical testing of pressure sensitive adhesives used in transdermal systems.• Designed test procedures for a TA Instruments texture analyzer.• Created Extrusion processes with single screw and twin screw extruders which were used in the phase 2 clinical productions of transdermal systems.• Developed and Maintained relationships with vendors of manufacturing supplies and materials.• Assisted with scale up of pharmaceutical patches from prototypes to manufacturing. • Designed bench top process flows with AutoCAD for prototype construction.• Utilized coating equipment for pressure sensitive adhesives.• Optimized hot melt mixing procedures for hydrocolloids and polymers. • Performed all service and maintenance on electro-mechanical parts for prototyping equipment.

Boston, Ma, Us

• Completed extensive training for TotalChrom HPLC software.• Analyzed the chemical content of transdermal patches using HPLC equipment.• Designed Tooling with AutoCAD for use in prototyping of pharmaceutical patches.• Performed skin flux and controlled release studies on pharmaceutical patches.• Utilized Instron equipment to perform physical testing of pressure sensitive adhesives.• Authored analytical test procedures used for training on HPLC and Instron equipment

• Designed office facilities for contracted clients• Conducted site surveys at customer locations to assess ergonomic needs.• Completed extensive training for AutoCAD 2000.

Industrial Engineering

Certificate, Unix System/C/C++ Programming