Worked on Covid-19 /Operation Warp Speed to provide vaccine for authorized Emergency Use during pandemic• Establish and manage raw material programs for internal and external (CMO) manufacturing sites• Experience with all types of quality events including OOS/OOT, deviations, CAPA, Change Control for internal and external manufacturing. • Introduce new raw materials for drug substance manufacturing including sourcing of newly created custom materials, designation of COA assays • Creation, editing and review of stability protocols, material specs, test methods, SOPs• Assess raw materials in conjunction with CMC, QA, Process Dev, Analytical Dev, Manufacturing Sciencesper EP, USP/NF, FCC, JP, BP, ChP, JPE • Manage routine testing and validation, qualification, suitability of analytical and microbial test methods. Transfer of these methods to CMOs and OTLs• Selects, manages, evaluates and train staff to ensure objectives are met.• Coordinate with multiple depts to prioritize sampling and testing to ensure completion per manufacturing schedule.• Facilitate multi-department (QC, QA, Supply Chain, Process Sciences, Analytical Dev, EHS, CMC) Material Review Board to set testing plans/methods and specifications for materials.• Regular meetings with vendors to discuss changes to current materials or introduce new materials.• Control and standard tracking, including production, trending, inventory and shipping.• Participate in audits and inspections, front room and back room. Update international regulatory filings and create CAPA.• Participate in GMP supplier qualifications and audits.• Establish new internal laboratory, including qualification of GMP class lab space, assay validation and equipment qualification• Software usage: Microsoft Office, LabVantage LIMS, Orion LMS, EQMS and EDMS, SAP

• Managing, monitoring and reporting Quality Control material schedules and results to ensure the department fully supports MacroGenics' cGMP validation, clinical and commercial activities, and programs.• Provides oversight of Quality Control personnel for sampling, testing and shipping-5 analysts. • Assay and lab operations data review• Interact extensively with QC management and analytical personnel, other departments, and business partners in order to gather, analyze, disseminate and report necessary data and information for material testing and release.• Present changes to materials and specifications to company upper management• Create, revise and review various GMP documents including SOPs, Test Methods, and Material Specifications • Perform all phases of quality records process, including Laboratory Investigations, OOS/OOT, Change Control, Deviations, CAPA and Non-Conformances• Strong knowledge of multiple compendia (USP, EP, BP, JP)• Oversee material qualification/requalification• Control and standard tracking and trending• Managing Contract Testing Laboratories: routine testing, method transfer, assay validation, investigations, auditing, qualification of new labs• Software: MasterControl for LMS, DMS and QMS, SAP, LabVantage-LIMS

• Perform GMP laboratory assays per FDA/USP guidelines including:o HPLCo PCRo FTIRo Specific Gravityo Appearance, pHo ASQL/ANSI quality inspection o Maintenance/Housekeepingo Ordering/Inventory• SAP• LIMS

Supervised 5-12 direct reports for biochemistry and microbiology analyses• Writing, investigation and review of Quality Records• Bulk Drug Substance Dispensing Coordinator: Batch Record, Stability, validation study samples. Duties include: • Coordinate with multiple customers and MSAT to determine samples to dispense per regulatory filing, requirements and recommendation • Coordinate required dispensing materials for each product-work with customer, Supply Chain, vendors to ensure supplies are available • Labeling regulations and required label information • Training lab personnel for new products • Maintain supply inventory in QC laboratories • Perform all investigations that pertain to dispensed samples, create and implement associated CAPA • Create BDS dispensing instruction forms for each customer/dispense, update applicable SOPs• Project driver for the implementation of GMP/GLP equipment and new testing methods• Inspection/Audit Core Team• Instrument Qualification/Validation performance• Quality/compliance guidance and decisions for lab activities• Personnel Management, career guidance and development• Writing and review of GMP/GLP documents• Daily Shift Task/Testing Prioritization• Audit and Inspection involvement with multiple clients and global regulatory agencies• Training coordination• Strong and regular communications within QC, across multiple depts. and with customers • Meeting facilitator • Data Review• Software: LIMS, Cerity, Trackwise, Dataguard, EndoScan, Softmax, SAP, Documentum, Syncade• Multiple Rewarding Excellence Awards

• cGMP/GLP Microbiology and Biochemical Analyses of Samples Utilizing the Following:• HPLC: Waters and Agilent Instruments, PA, SEC/GPC, Sialic Acid, Reverse Phase Chromatography • UVIS: Shimadzu, Varian Cary, Perkin Elmer and Beckman Spectrophotometers• Conductivity/pH,Osmolality • Total Organic Carbon: Sievers 800, 900, M9 Analyzers • Bioburden-Membrane Filtration, Spread Plate, Pour Plate• Endotoxin: Kinetic Method, Gel Clot • Biological Indicators: Strips and Ampoules • PCR• Analyte Determination: Nova Bio-Profile• ELISA• Assay Trainer/Training Coordinator• Reagent Preparation• Production Sample Logistics: • Sample receipt and tracking • Problem Solving and troubleshooting• Shift Task/Testing Coordination• Writing: Deviations/Laboratory Investigations/Change Control • Regular and Frequent Verbal and Written Communication. • Other shifts and QC Groups. • Other Depts within the Company• Software: LIMS, Cerity, Trackwise, Dataguard, EndoScan, Softmax, SAP, Documentum

Part of the Quality Team that was integral in obtaining FDA approval for a new influenza vaccine. • Processing and Retention of FDA Regulated Manufacturing Samples which includes, but is not limited to:• Quality inspection of intermediate and finished product• Ensuring delivery to the appropriate facilities• All necessary documentation for testing• Performance of pH, color/appearance and sterility assays• Interfacing with testing facilities.• PQE investigations for improper sample processing.• Coordinate, track and disseminate all testing data • Water System Monitoring (WSM)• Performed USP assays: TOC, endotoxin (gel clot), conductivity, and bio-burden• Trending of data within Excel• Issued weekly and monthly reports• Pulling of WFI samples• Controlled Materials (GMP Regulated)• Quality inspection: ASQL/ANSI sampling, various assays, physical measurements, and documentation• Processed raw materials for submission to “outside testing labs” (OTL)• Document QC sampling/inspection of GMP controlled materials in SAP • OOS investigations for raw materials or finished product• Creation and Revision of SOP’s• Change Control Requests for validated lab instruments.• SAP• Requisitions to purchase lab instruments, supplies, and OTL purchase orders. • Utilized for inventory of GMP controlled materials• Meeting leadership/attendance• Leader weekly QC Update Meeting• Attend Daily and Weekly Interdepartmental Production Planning Meetings• Attend 2X weekly conference calls with OTLs and other company sites• Routine environmental monitoring (EM)• EM samples: Incubation, ID submission, and data trending• EMIR Committee• PQE, EM, WSM, and OOS investigations as they pertain to all duties performedAdditional duties of lab maintenance, documentation and logbook review, assay performance, GMP equipment monitoring, and employee training.  Director’s Award for outstanding job performance in 2003