Matt Applegate Email & Phone Number

Gainesville, Ga, Us

Auckland, New Zealand, Nz

-Oversee site P&L of ~$25m-Achieved inventory reduction of more than 50% YOY 2023 vs 2024-Achieved revenue growth of almost 40% YOY 2023 vs 2024-Oversee site staff with ~100 direct and 10 indirect staff-Oversaw staff growth of 20% YOY 2023 vs 2024-Responsible for all manufacturing attainment in the US-Responsible for supporting all business development projects for the site-Responsible as the executive leader for direct customer relations-Responsible for annual capital investment projects at the site, current projects ranging from $10K - $2m-Responsible for HSE, Production, Engineering & Maintenance, Supply Chain, Quality Control, Project Management, and MSAT-Active member of the global Senior Leadership Team-Responsible for the strategic vision of the Fort Dodge manufacturing site-Responsible for collaboration with local and regional government teams-Responsible for supporting recruitment activities for the Fort Dodge site

-Active member of the Medgene Labs executive leadership and management team-Responsible for 7 departments and 26 FTEs: Viral and Bacterial Manufacturing, Fill and Finish, Process Development, Warehouse and Logistics, Quality Control, Facilities and Maintenance-Leading all manufacturing efforts for the company-Provides strategic oversight and direction to the manufacturing site-Developed manufacturing and site KPIs-Developed and responsible for maintaining the site master plan-Responsible for manufacturing and site P&L (~$10m annually)

Burlingame, Ca, Us

Burlingame, Ca, Us

-Collaborate with commercial management teams to establish strategic commercialization plans.-Establish strategic site master plan.-Lead transition of site into an operational commercial manufacturing facility.-Drive process improvements to decrease manufacturing costs.-Perform detail cost analysis of manufacturing operations using process modeling.-Lead the business development activities to initiate a new Contract Manufacturing Organization within the company

Burlingame, Ca, Us

Establish and direct all manufacturing site operations for the Elwood, KS manufacturing site. Manufacturing operations to include biologic and pharmaceutical manufacturing under regulation by USDA, FDA, and EMA.-Design and renovate manufacturing facility to enable large scale GMP manufacturing capabilities. -Design and renovate facility into state of the art process development laboratory.-Recruit staff for all departments.-Lead product transfer from development into commercial scale fill/finish manufacturing.-Lead product transfer from development into commercial scale bio-manufacturing.-Establish and maintain facility operating budget.-Establish clinical manufacturing laboratory for non-GMP clinical material.-Establish site supply chain, warehousing, logistics, and related ERP systems.-Lead commercial manufacturing equipment specification, procurement, and operation.-Establish site safety, security, and crisis management plans.

Blue Bell, Pa, Us

Lead Process Engineering for the Midwest region. Lead a group of 4 global oriented process engineers.Lead Process Engineering for facility expansions and modifications for companies in the animal health vaccine production facilities, animal health pharmaceutical production, food flavoring manufacturing, and microbiological testing.Projects encompassed manufacturing operations for aseptic filling, vaccine and bacterin antigen production, small molecule production, aseptic formulations, flavor spray drying, active pharmaceutical ingredient (API) manufacturing, microbiological testings, nucleic acid vaccine production, and animal sedatives.Deliverable's included manufacturing operations capacity analysis, block flow diagrams, process flow diagrams, mass balance analysis, process oriented utility capacity and usage evaluation and analysis (Water-for-injection, USP Purified Water, Clean Steam, Process Gases, Process chilled water, process black steam, compressed air), Process and Instrumentation Diagram (P&ID) development and quality control, bio-process method consultation, equipment specification and bid tabulation, construct-ability review, equipment and instrumentation specification review, and project man power estimation,.

Waltham, Ma, Us

Led multiple teams across operations, including two Product Performance laboratories, Process Control, Media and Process Development, Operations HSE, Blood Supply Chain and site Research and Development (7 departments with 52 FTE’s). Worked on internal and external product transfers, production lab design and build, new ISO 11133 adaptation/certification, multiple Kaizen teams, driving 5S into multiple departments, design and renovation of a microbial testing laboratory.o Primary representative of the Operations team on all custom productso Renovate blood manufacturing facility - $500K investmento Increase internal blood supply from 50% to 65% while driving costs down to 15% below outsourced blood providing capabilities to produce 150 million plates and 35 million tubeso 50% reduction in 2015-over-2014 QC discards, was on track to reduce 2016-over-2015 discards by another 50%

Libourne, Fr

-directed operations for 10 production departments across two sites. Included Live and Inactivated Batching, Inactivated Filling, Live Filling/Lyophilization, Bacterial Antigen Production, Custom Vaccine Production, Tissue Culture Antigen Production, Chicken Embryo Antigen Production, Egg Pre-Incubation, CAV and Diluent Production. Consisted of 7 Supervisors, two Assistant Managers, one Site Manager, and 55 technicians. -Oversaw multiple projects which included a building expansion and installation of two 20 meter lyophilizers (~$20MM CAPEX), design of a tissue culture bioreactor suite for viral antigen production (~$5MM CAPEX), renovation of a bacterial fermentation suite (~$1MM CAPEX), and represented operations as the subject matter expert for the design of a 45,000 sqft viral antigen and aseptic batching and filling production building.

Libourne, Fr

-managed 6 departments (Live and Inactivated Batching, Inactivated Filling, Live Filling/Lyophilization, Bacterial Antigen Production, Custom Vaccine Production, and Tissue Culture Antigen Production) consisting of 6 Supervisors and 30 technicians-managing daily activities for all reporting production departments-reviewing and approving all formulations for live and inactivated semi-finished goods-performing active role as the primary industrial operations representative for a large building expansion to include new utility infrastructure, lyophilization units, preparatory labs, batching/formulations suite, bioreactor suite and aseptic filling lines-actively performing role as industrial operations representative as a core team member for an international product development team-performing production planning for live (lyophilized and frozen) and inactivated semi-finished goods, bacterial antigen, and non-cell associated viral antigen -analyzing semi-finished goods planning versus sales forecast as provided by demand resource planning system-analyzing antigen planning versus sales forecast of semi-finished goods as provided by manufacturing resource planning system-controlling expense budgets for all reporting departments-achieved 54% reduction in the number of contaminated fermentations from 2011 to 2012-achieved 97% reduction in the number of contaminated inactivated semi-finished units from 2011 to 2012-launched Total Productive Maintenance program across multiple departments-improved bacterial fermentation yields for multiple isolates by up to 70% from 2012 to 2013-performed successful validation of a large scale inactivated blending and filling line-performed successful R&D transfer, implementation, and validation of a novel dual emulsion and batching process-initiation of career and supervisory/management skills development plan for reporting supervisors, laying the ground work for implementation of succession planning

Libourne, Fr

-managed 4 departments consisting of 4 Supervisors and 20 technicians-managed daily activities for all reporting production departments-reviewed all formulation templates to ensure accuracy-reviewed and approved all formulations for live and inactivated semi-finished goods-assisted in establishment of SIP processes throughout the site-lead the transition of live batching activities between production suites and buildings-lead project to replace 2 fermentation vessels within the custom vaccine production and renovation of the production suite including develpment of the operating system and processes (~$800K CAPEX)-acted as the industrial operations representative as a core team member for an international product development team-planned production of inactivated semi-finished goods and bacterial antigen planning-directly involved in implementation of a Demand Resource Planning (DRP) and Manufacturing Resource Planning System (MRP)(JD Edwards)-analyzed semi-finished goods planning versus sales forecast and manual planning model-analyzed antigen planning versus sales forecast of semi-finished goods and manual planning model-controlled expense budgets for bacterial fermentation, batching and formulations, and inactivated filling-achieved 57% reduction in the number of contaminated fermentations from 2010 to 2011-improved raw material usage resulting in a $30,000 savings for 2011-attended a three day Project Management Training course-worked on the development of a site wide aseptic training course hosted by S2 Insight-improved bacterial fermentation yields for multiple isolates by up to 40% from 2011 to 2012

Libourne, Fr

-managed 2 departments consisting of 2 Supervisors and 10 technicians-managed daily activities for standard licensed and custom bacterial antigen production-lead the project for design, development, installation, operation, validation, and process qualification of a bleed and feed tangential flow filtration skid to concentrate live bacterial antigen-re-established the bacterial antigen safety stocks from depletion while maintaining production needs -involved as the industrial operations representative as a core team member for pipeline products-coordinated pre-licensing serial production-developed Standard operating procedures and Outlines of Production-identified needs for industrial operations to support development of pipeline products-controlled expense budget for bacterial fermentation groups-performed raw material resource planning-lead the relocation and reintroduction of a live bacterial product (~$600K CAPEX)-established an investigation and root cause analysis procedure for the site-lead the renovation of a bacterial fermentation suite while maintaining production activities-actively involved member of an international team to improve aseptic and sterile processes across the company-implemented the first on-site validation procedures-developed entirely new production documentation for the bacterial fermentation groups-developed and implemented a site wide switch from carboy usage to single-use-bag technologies-developed and implemented sterile vessel sampling systems-worked with the Hays group to develop job grades and a performance management system-implemented a Total Preventative Maintenance (TPM) program within the bacterial fermentation departments-directed and implemented numerous process improvement initiatives-implemented a training model for improved development of technicians

Leverkusen, North Rhine-Westphalia, De

In addition to previous duties:-performed human resource management responsibilities-maintained all production deviation events for HA production-organized all calibration and maintenance activities within the production schedule-performed product releases for raw materials-performed duties as assigned by the production manager-organized and supported all validation activities within the HA area-managed critical system change controls for HA production-approved work orders for calibration and maintenance completions-supported lean manufacturing initiatives-supported production process development of novel drug products into current manufacturing areas-tracked, maintained and supported production expense budget-developed reporting personnel-supported cross functional operator training-supported and track site safety metrics-took active role in the reduction of Cost of Goods Sold (COGS)

Leverkusen, North Rhine-Westphalia, De

In addition to previous responsibilities: -supervised a team of four production technicians-coordinated production plant shutdowns-involved in hiring of new production technicians-created and maintained the area production schedule based on forecasted product needs-created and maintained sampling schedule with Quality Control-maintained inventory of critical consumables for HA production-played active role in further process based risk analysis-mentored and tested personnel using the operator certification/development program-responded to quality alarms and determined corrective actions-played active role on internal auditing team-ensured all department training was up to date-continued to ensure production activities within department were performed under FDA regulations-reevaluated standard operating procedures to ensure they were within revised corporate guidelines

Leverkusen, North Rhine-Westphalia, De

In addition to previous responsibilities:-assisted in the development of an operator certification/development program-maintained batch production records and complete review of finished production records on a timely basis-assisted in the development and review of validation protocols-took part in the multi-week Bayer International Management Simulation (BIMS)-wrote process deviation reports-developed and maintained production lot summary files-worked in a 10k class clean room to perform microbial inoculation of Chemically Defined Medium

Leverkusen, North Rhine-Westphalia, De

In addition to previous responsibilities:-revised Batch Production Records and SOPs-reviewed batch production records and SOPs-trained coworkers-involved in process and equipment risk analysis-actively involved in installation qualification and operational qualification of numerous pieces of equipment including stainless steel fermentors, Carr P18 ultrafuge, portable processing vessels, various microfiltration skids, bleed and feed plate and frame TFF system, and clean-in-place skids-actively involved in process qualification and validation to meet 21 CFR compliance of a multi-stage 7 week process for an active pharmaceutical ingredient

Zurich, Zurich, Ch

-Hyaluronic Acid production (consisted of multi-pass fermentation, flow through continuous pass centrifugation, cell removal microfiltration, bleed and feed plate and frame ultrafiltration, concentration, and diafiltration, clarifying filtration, sterile filtration, alkaline hydrolysis, and ethanol precipitation)-demonstrated a working knowledge of cGMP's-assisted in process improvement-assisted in process troubleshooting-developed Standard Operating Procedures-assisted with vessel temperature mapping and steam in place validation-actively involved in production of Engineering Batches of active pharmaceutical ingredients-performed safety evaluations-used a Process Control System (PCS)-proofread Batch Production Records, SOP's, and Wonderware InBatch recipes

Emporia, Ks, Us

-prepared culture media-monitored and stored food product samples-maintained stock cultures for Microbiology and Pathogenic Microbiology Laboratory classes-performed ELISA and DNAH assays-monitored and maintained a mouse virulence study-observed and documented organism occurrence-performed statistical analysis of study data

Master'S Of Sciences, Microbiology

Bachelors Of Sciences, Microbiology