Patrick Gragg Email & Phone Number

Apex, Nc, Us

Durham, North Carolina, Us

Morrisville, North Carolina, Us

Establish best practices and continuous improvement initiatives, in collaboration with ProcessDevelopment and Research department Directors.• Assisted with initial lab buildout and equipment asset procurement while working with Supply Chain onvendor contract negotiations.• Oversee and manage all utilities and equipment calibrations with outside vendors as head of facilitiesmanagement.• Draft written SOPs and protocols establishing lab safety and chemical inventory management.• Established lab safety, chemical safety, and biological safety action plans in the event of an excursion,contamination, or exposure.• Collaborate with Triumvirate Environmental to track and ensure all lab personnel receive yearly trainingincluding Blood Borne Pathogen Training and Chemical/Biological safety.• Work closely with Vice president of Finance to assist in financial analysis in creating lab related capitalexpenditures and AOP planning related to all facilities operations.• Manage the Rees Scientific Monitoring system for sensitive lab equipment needing continuous remotemonitoring.• Oversee the induction and implementation of a master asset management system via LabGuru forequipment PM and calibration scheduling and tracking reducing lost time, thus proactively improving thesystem in place.• Provide facilities updates, site work plan, and conduct in-person walk-throughs as scheduled with localFire Department and associated Inspectors to ensure all regulation requirements are satisfied in that allsafety equipment has passed inspection, emergency lighting and exits are in working order andunobstructed, all chemicals are stored in the appropriate categorization and within controlled areas, etc.• Created robust freezer sample inventory tracking and management system. Established and maintainedLab 6S organization management with monthly inspections, thus improving the overall efficiency andcleanliness of the lab.

Durham, North Carolina, Us

Ensured downstream Process Development was represented on the Safety Committee as the primaryrepresentative for the DSPD lab performing routine safety inspections reporting findings to the HSEmanager and ensured the group was compliant within applicable safety regulations pertaining thechemical hygiene/safety and hazardous waste management.• Spearheaded the DSPD 6S team and established/improve workflow and identify areas of continuousimprovement.• Head of and coordinator of the Bi-Weekly DSPD lab admin meeting sharing updates/performance ondepartment initiatives and projects.• Determine areas for gaining lab efficiency, coordinate with individual groups and ensure harmonizedimplementation of best practices such as the storage of all hazardous material, usage, proper disposal,and visual management practices.• Directly managed the harvest freezer inventory system employing the Power BI platform to inventory andtrack all movement of clarified harvest and process intermediates including coordination with offsitestorage vendor(s), thus vastly improving the overall efficiency of processing large bulk harvest material(s)into a controlled system.• Coordinated all client material shipments using an electronic shipment request form that wasimplemented for downstream process development department using standard and specialized vendors.• Ensured all Laboratory equipment was calibrated within the appropriate forecasted schedule and workwith off-site vendors for routine Preventative maintenance and calibration for numerous complexequipment including but not limited to AKTA Avant platforms and Solo VPE Spectroscopy systems.• Ensured the required chemical raw materials are available for forecasted development process needs andorder additional supply as needed within approved vendors and research additional vendors to maintaina well-rounded supplier system.

Battle Creek, Michigan, Us

Provided support to Operations relating to quality and food safety Including routine inspections ofmanufacturing lines and processes.• Maintain the position of the lab SME (Subject Matter Expert) for all lab equipment includingtroubleshooting issues when equipment malfunctions and ensure all scheduled PreventiveMaintenance was performed.• Trained other lab technicians on troubleshooting techniques for equipment.• Performed weekly 5S inspections to ensure a lean methodology that improved efficiency andeliminated waste within the QC lab area.• Worked with Corporate RQT on new equipment and calibrations of current equipment through currentstandards or other tests (ex. Vacuum Oven Testing, Color Analysis, etc.) Monitored all receiving, rawmaterial, in process, and finished product controls and tests.• Assisted to resolve or minimize out-of-specification conditions and foreign substance contamination ofraw materials, in-process, and finished products through observation, identification, notification,documentation, isolation, audit, and disposition.• Assisted to resolve and manage Quality incidents relating to weight, organoleptic (taste, texture, andflavor), and appearance of product.• Resolved and manage Food Safety incidents relating to chemical, physical, and biological hazards whichcould result in product holds.• Maintained various Food Safety (sanitation, quality, pest control, HACCP) data, manuals, documents,and files ensuring GMP Compliance with all employees, contractors, and visitors are adhered to throughauditing, data collection and/or past evidence documentation.

Baar, Switzerland, Ch

• Managed the SLIM-RV system (request, pull, and organized LWRs for inspection, making sure results areentered/verified/approved in a timely fashion).• Scheduled and maintained pulled vials which were to be prepared for bi- monthly inspections.• Worked with the Continuous Improvements Supervisor on Stability Protocols and studies concerningproduct shelf life and potency evaluation for sterile manufactured products and sterile diluents.• Authored several stability protocols involving sterile manufactured COCAS diluent to determine thecause and effect for pH variations.

Baar, Switzerland, Ch

- Work with all department Managers and Supervisors to investigate standard deviations within all company SOP and processes-Initiate and drive CAPA items to implementation and closure-Receive, investigate and coordinate with Regulatory Affairs to route customer complaints to resolution and closure-Responsible for the participation in supplier and internal audits-Participated in a supplier audit of Gerresheimer Glass Inc. in Chicago Heights, IL in July 2018-Responsible for the initiation and routing of numerous SOP changes, updates and Change Requests-Observe and ensure all process qualifications and validation are within cGMP and SOP requirements during Media Fills and any process change/requalification

Baar, Switzerland, Ch

-Data entry for all testing and stability within the QC Microbiology and Chemistry laboratories-Head all supply and raw material orders for the entire QC department-Submit extraction, SD/SEV (drug products), and chemistry samples within the database and logbook for all associated/required testing-Coordinate with QC Laboratory Manager, QC Micro and Chemistry Supervisors to locate additional vendors and suppliers that are more cost effective and lean-Created new and additional vendor/supplier list with all materials ordered and categorized by cost and frequency of order-Responsible for entry and data integrity of all environmental/personnel monitoring data concerning all classified ISO areas-Responsible for maintaining and operating the Lighthouse Particle Monitoring System manifold and execute samples/resamples of particle excursions within classified ISO and manufacturing areas

Baar, Switzerland, Ch

-Oversee and assist in daily laboratory practices-Analyze and ensure the sterility and quality of manufactured product-Ensure working environment is sterile and free of possible bacterial and/or fungal contaminants through environmental monitoring practices-Converse and cooperate with other departments, as well as, management to investigate any excursion experienced to ensure that manufactured product has not been impacted and the safety thereof is verified within FDA qualifications and guidelines-Daily sterility/environmental data entry and retrieval with MODA software

Brentwood, Tn, Us

- Extensive work with customers to ensure an effective and productive employee/customer relationship to establish customer loyalty and rapport- Substantial work with employee relations concerning the ability to build confidence and trust between employees and management - Oversee the operations of customer transactions, returns, complaints, special ordering, and correct/precise closing and opening operations- Maintain order budget, data entry into computer records, accounts payable & accounts receivable- Numerous inventory processes and procedures to ensure effective processing of received and transferred merchandise - Correct and effective opening and closing procedures including: bank procedures and processing of cash and paperwork- Processing and handling of heavy equipment and purchases by hand and forklift when needed- Forklift operations including: move, relocate, stack, and count merchandise/equipment; unload inbound shipments; pull and prepare product for shipment; efficiently transfer product from staging/storage area to designated pick up areas

Bachelor'S Degree, Business Administration, Management And Operations

Associate Of Science - As With Honors, Associates Of Applied Science