Strategic and operational leadership of Precigen GMP manufacturing facilitiesLead commercialization of GMP Manufacturing and Quality Control facilities including capital upgrades and GMP system updates for enhanced compliance, while improving efficiency and effectiveness of support systems.Ensure proper Facility, Utility, and Equipment operation through enhanced maintenance systems. Drive compliance and system suitability via Validation and Metrology process update and execution. Build improved safety culture with increased formality of safety program.

Department Head for Catalent’s flagship Gene Therapy site representing Equipment Engineering, Automation, Metrology, Facilities, Validation, and Security to the Site Leadership Team (SLT)Owner of site capital portfolio including $250MM+ projects and average yearly CAPEX over $50MMDrove 25% Repair and Maintenance budget reduction and improved schedule adherence by 25%Lead equipment selection, building/process design, Supervisory Control and Data Acquisition (SCADA) / Manufacturing Execution System (MES) / Electronic Batch Record (EBR) / Network Attached Storage (NAS) backup implementation, and equipment/facility aspects of new client start-upCoach and mentor team members throughout 90+ person department to enable strong culture

Lead Process and Automation Engineering teams at Catalent’s flagship Cell & Gene Therapy siteResponsible for the life-cycle of process equipment, computerized equipment, and automation systems including induction, commissioning, calibration and preventive maintenance plan development, troubleshooting/corrective maintenance, and decommissioningBuilt Automation team from 2 to 9 members, establishing critical structures and systems to enable success.Represent Process and Automation Engineering teams in FDA, client, internal, and other regulatory group auditsSupport process and automation decisions for new facility build-out including equipment selection, process design, shop floor network, SCADA, and automation infrastructure for 8 production suites

Manage Process Engineering department providing equipment commissioning, maintenance, and reliability support for the Catalent Cell & Gene Therapy Maryland sitesBuilt team from 5 to 13 engineers in 9 months, enabling enhanced support of Maryland sitesLed process engineering support for capital projects including new products/suites and suite changeoverStarted manufacturing associate mentorship program to create internal pipeline of engineering talentDeveloped engineering programs for team training, reliability analyses, and improved preventive maintenance for site equipment to improve team efficiency, decrease downtime and maintenance costsFounding member of Employee Council improving site performance and morale

Director-level leader on site operational excellence process team responsible for operational management including deviation investigation, project implementation, process improvement, and safetyManage site portfolio of capital projects ($1-5 MM) including:- Construction, installation, and qualification of Autogenous production facility- formulation, emulsification, and filling, equipment including automated Clean-In-Place (CIP) and QC labs- Design and implement HVAC isolation for Select Agent processing, Select Agent clearance- Increased cleanliness and sterility by implementing automated cleaning in four processesReduced fermentation vessel steam cycle time by 50% through piping and controls optimizationGenerated preventive maintenance (PM) program for new automated cleaning equipment and improved plans for existing inoculation, incubation, fermentation, and automation equipment

Member of the Manufacturing Science and Technology (MSAT) team supporting manufacturing operation and technology transfer through design, engineering, and process scale-up activities.Developed the site extractable and leachable (E&L) evaluation program. Conduct E&L assessment for all products/processes on site.Lead complex technical investigations through in-depth assessment and Root Cause Analysis (RCA).Identify and implement process improvements to maintain an Operational Excellence environment and enhance compliance across the site through process monitoring, data summary, analysis, and presentation.Design and implement corrective and preventive actions (CAPAs) to reduce process variability, improve product quality, and streamline production processes.Author, revise, and review technical documents i.e. investigation reports, CAPA and deviation reports, master batch records, quality control sheets, material specifications, and Standard Operating Procedures (SOPs).Organize, manage and improve operations activities to support new product/process development for manufacture of clinical and commercial products according to GMPs, ISO, EU, and ISPE regulations.

Equipment Validation Project ManagerRemediation in response to FDA Form 483 and Warning Letter. Led a 27 person team to develop and implement improved cleaning and equipment validation programs.- Conducted multi-million dollar upgrades to manufacturing suite to increase compliance. - Developed FDA/ISO regulation compliant Validation Master Plan, Cleaning Master Plan, Cleanroom Qualification Master Plan, Equipment Qualification Master Plan, and supporting systems/procedures.- Developed and executed updated Installation, Operation, and Performance Qualification (IQ/OQ/PQ) for cleanroom, air handler, heat sealers, formulation tanks, filling equipment, and autoclave. - Created and updated procedures for aseptic manufacturing to ensure compliance.Member of a dedicated cross-functional team responsible for investigation and resolution of process deviations to reduce recurrence and ensure product quality.Led deviation investigations, gathering data through interview and process observation, analyzing trends, and conducting Root Cause Analysis (RCA) to identify true cause and product / process impact. Developed a system to ensure effective, on schedule Corrective Actions / Preventive Actions (CAPA) including an action plan generation tool to establish milestones and allocate resources appropriately.Led the site Engineering / Utility Change Control program, establishing requirements for changes to equipment, facilities, and utilities to mitigate product impact and ensure cGXPs are followed.

Member of a dedicated cross-functional team focused on resolving quality non-conformance records efficiently and sharing of best practices throughout the site.Managed the Problem Records (PRs) for Facilities & Engineering, Manufacturing Science and Technology (MSAT), Research Cells, and Endotoxin Detection as the department TrackWise Subject Matter Expert (SME)Conducted Root Cause Analysis (RCA) with a systematic approach utilizing engineering, scientific, and statistical methods to identify true cause and develop effective Corrective Action / Preventive Actions (CAPAs).Performed interviews and process observations, coordinated investigation teams, tracked and evaluated progress, and prepared investigation reports to aid in PR resolution.Coached and mentored PR Authors on quality, consistency, technical writing, RCA, and product impact analysis for right-first-time practices and on-time closure.Actively identified, drove and implemented error prevention / continuous improvement initiatives using PR trending, cGMP knowledge, and LEAN Six Sigma philosophy.Led the restructure of the change control process for improved clarity, efficiency, and compliance.Tracked, analyzed, and trended all site PRs to present to site and global leadership.Participated in advanced Root Cause Investigation Training.

Member of a cross-functional process validation group for the remediation and improvement of the mixing and filling process for parenteral solutions.Developed and executed protocols for the evaluation of solution homogeneity throughout the solution preparation process.Managed engineering projects, including scheduling equipment and materials for validation runs.Participated in FDA, TGA, customer, and internal audits.Conducted laboratory scale and engineering studies on process understanding.Performed mixing and filling validation runs following SOPs, cGDPs, cGMPs and plant quality and safety requirements in both aseptic and terminally sterilized production areas.Tested critical process parameters to assure reliability and quality and utilized proper documentation to support the associated process and results of validation.

Worked in a team of Bucknell University students, faculty and staff, along with Geisinger Medical Center physicians and administrators to develop a novel endotracheal intubation device.Collaborated with Geisinger Medical Center Emergency Department physicians to evaluate issues in patient care and analyze benefits and feasibility of solutions.Created several prototypes of the design using SolidWorks and 3D printing to evaluate for effectiveness and manufacturability.Maintained a Design History File (DHF) throughout the design process from problem selection to regulatory filing.Presented our design process and a working prototype at the Bucknell Senior Design Expo.

Developed a portable syringe pump with no external power source in a three-week intensive design process.Conducted a finite element analysis in COMSOL Metaphysics to model the carotid artery during a vasovagal response and assess blood flow to the brain.Designed a PID controller in LabVIEW to mimic an insulin pump; created a re-circulating flow loop to model the metabolism of insulin in the body; combined the two systems to create a working model of the regulation of insulin in a diabetic patient.Assessed and benchmarked a medical device; developed improvement plan using market, policy and intellectual property research. Prepared 510(k) filing for the improved device.Designed and created a re-circulating flow loop to model the metabolism of caffeine in the body.

Sustainable Engineering course designed to develop professional responsibility and sensitivity to topics impacting engineering including ethical, environmental, economic, regulatory and cultural issues.Daily visits to engineering sites such as research universities, natural and cultural resources, and industrial facilities.Interaction with executives, government officials, students, professors, and employees of various companies.

Completed Institutional Review Board (IRB) Certification Training in 2010.Volunteer Co-interventionist for NIDDK Treatment of Early Childhood Overweight: Pilot Study, 4-8 year old participants in manual guided Group Family Lifestyle Modification Program in Primary Care. Research Team member for NIAAA Pharmacogenetic Response to Naltrexone for Alcohol Dependence focused on marketing/recruitment and observation of medical management sessions.Team member for dLife-Geisinger Lifestyle Modification Media Program: Type 2 Diabetes in Primary Care. Attended meetings, shared medical visits to help collect data; involved in preliminary analyses and preparation for national meeting presentations.

Performed research under the guidance of Dr. Daniel Rukstalis, Director, Department of Urology, on a potential application for a new hollow fiber catheter for the treatment of Peyronie’s disease.Collaborated with the manufacturer, Twin Star Medical, to determine the most effective methods for drug infusion.Observed cryotherapy for the treatment of prostate cancer and other robotic surgeries on a DaVinci® surgical system.Completed medical ethics training.

Employed in the Building Efficiency business unit, working with engineers and IT on a patented configuration and selection software that supports a $175 million+ line of business. Tested configuration of equipment selections; evaluated new pricing configuration by testing price keys on bill of material database.