o Accountable for start up activities and GMP readiness of cleanroom areaso Develop and maintain timelines that are achieved to meet overall site /company goals and objectiveso Establish training programs for manufacturing staffo Establish partnership with Process and Analytical development and ensure seamless process technology transfer from PD to GMPo Be part of the core team to startup GMP cleanrooms, including but not limited to, room testing and releases, EMPQs, equipment IOQs, etc.o Contribute to facility commissioning and validation activities, as needed.o Contribute to selecting, and ordering GMP equipment, and onboarding new equipment into GMPo Represent PackGene GMP operation in project meetings and be a subject matter expert in GMP execution related topicso Develop and maintain compliant standard operating procedures of GMP operationso Maintain oversight of compliant operations, ensuring an environment, health and safety cultureo Maintain strong relationship with internal and external stakeholderso Exemplifies and drives a Quality Culture throughout the organization.o Supports hiring and supervision of manufacturing personnel.o Analyze resource estimates, including budgeting and headcounts.o Owner of CAPAs, and change controls.o Participate and guide deviation investigations.o Other tasks as assigned

o Quality liaison aiding the coordination and scheduling of product release, closure of quality records and communication between Internal and External functional areas.o Created and managed communication plan for Internal and External functional areas to aid in the time management and efficiency during critical client interactions related to Quality topics.o Partnered with Internal and External functional areas as part of the Change Control process to determine Quality Impact for Clinical and Commercial Products. o Supported as a process Subject Mater Expert (SME) for QA during routine production as well as non-routine events, Investigation, and CAPAs specific to customer.o Reviewed and approved Deviations and CAPAs for Commercial Products.o Participated in departmental Functional Leadership Team meetings to provide input on departmental strategic decisions. o Managed projects from concept to completion by creating and managing project plans while collaborating cross functionally to ensure right first time, as well as tracked lessons learned and provided adequate training to impacted areas. o Quality Assurance representative in the Joint and Internal Project Teams serving as the SME for any customer related quality topics. o Monitored and documented the Key Process Parameters (KPI) Metrics for both Internal and External Leadership. o Managed Quality Agreement (QAA) and Annual Product Quality Reviews for Commercial Products.o Reviewed and approved various product specific documents such as Continued Process Validation Reports (CPV), Material Assessments, Equipment Validation protocols and Summary Reports, Risk Assessments (RA), Certificate of Analysis (CoA), Manufacturing Batch Records (MBR), Work Instructions (WI), Quality Control Sample plans (QCSTF), Standard Operating Procedures (SOP), etc. o Supported customer and regulatory audits.o Served as a leader and mentor to entire Quality team for Commercial Products.

o Managed disposition of manufactured batches, which includes maintaining a batch release tracking system, partnering with other functions to close out all required deliverables required to support the disposition of batches, which includes but not limited to executed batch records, deviations, change controls, Lab Investigations and Equipment Trend Reports, Environmental Monitoring reports.o Created batch release tracking system to improve lot by lot assessments and provide better visual management to the internal and external Senior Leadership Teams.o Reduced backlog of released batched within 3 months of being in position with the creation of the tracker and planning hyper care interdepartmental meetings and aided on task completion as needed.o Mentored/coached junior staff members as a SME for any Manufacturing and Quality related topics.o Partnered with Inspection Management team to identify gaps in the Quality Systems.o Identified and implement changes to the current Quality Systems to improve compliance,effectiveness and efficiency.o Maintained quality systems and cGMP compliance for the business by ensuring that all teammembers complied with processes, procedures, and instructions for all activities in which theteam participated in.o Followed job safety procedures, attended required health and safety training, proactivelypromoted safety at work, and promptly reported actual and potential accidents and injuries.

o Supported as a process Subject Mater Expert (SME) for Commercial Manufacturing during routine production as well as troubleshooting during non-routine events.o Was responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contributed to quality, cost, on- time delivery, and right first-time performance.o Mentored, managed and had oversight of other Manufacturing Project Associates, Specialists, and temp labor.o Managed and monitored: Technology transfers, campaign support and readiness, capital projects, Process specific Change Controls, Corrective and Prevention Action (CAPA’s), Laboratory Investigation Reports (LIR), Validation activities.o Owned and drove internal and cross-functional improvements projects that supported department Key Performance Indictor (KPI’s), with a focus on cost, innovation, on-time delivery, and quality.o Managed projects from concept to completion by creating and managing project plan, worked cross-functionally to ensure right first time and provided adequate training to impacted areas.o Provided client updates regarding manufacturing activities and fostered positive communication for project success.o Managed the building completion of a third commercial Manufactured Process Area including input of project needs to building contractors, approval of final floor plan, equipment purchasing, coordination of establishment of equipment for commercial manufacturing use, equipment qualification and final release for use, EMPQ and full room release for validation and subsequent GMP production.

o Responsible for aseptic processing of clinical and commercial grade product, including adherent and suspension cell culture, purification, formulation and filling activities according to approved production records and cGMPs.o Served as a SME for the commercial Manufactured Products as well as provided training to new hires.o Investigated and troubleshooted unexpected events via Compliance Systems in the form of Deviations.o Reviewed, wrote, and executed batch records and SOPs.o Supported in maintenance cleanroom environment below alert limits by following establishedcleaning practice.o Maintained material and equipment inventory of cleanroom suites and support areas.o Performed environmental monitoring as needed.o Helped managed the startup second Commercial Manufacturing Process Area within the facility.o Managed smoke studies and supported EMPQ prior to startup of second CommercialManufacturing Process Area.o Managed the Aseptic Process Simulations for each Commercial Manufacturing Process Area. o Served as an acting lead and mentor to junior staff within the Commercial ManufacturingProcess Area.

o Responsible for aseptic processing of clinical grade product, including cell culture, purification, formulation and filling activities according to approved production records and cGMPs.o Provided training to new hires.o Investigated and troubleshooted unexpected events via Compliance Systems in the form of Deviations.o Reviewed, wrote, and executed production records.o Supported in maintenance cleanroom environment below alert limits by following established cleaning practice.o Maintained material and equipment inventory of cleanroom suites and support areas.o Performed environmental monitoring as needed.o Maintained cGMP practices.

Maintained clean room/manufacturing operations and techniques following approved instructions and procedures.o Expert in Hands-on adherent cell culture with effective use and maintenance of good aseptic techniques including cell isolation, thawing, cryopreservation, sub-culturing, and harvest.o Maintained accurate and timely paper and electronic manufacturing records, notebooks, records and logs.o Documented and maintained LUMACs on assigned equipment.o Maintained clean room cleanliness, equipment inventory, and maintenance of storage tankareas.o Managed first in/first out of materials used during manufacturing activities.o Provided new hire training for aseptic technique, cell counting techniques and general manufacturing activities.o Conducted investigations for deviations within the manufacturing process and evaluated datarelated to unexpected events and proposed corrective solutions.o Attended and participated in group and project meetings.o Recommended changes to procedures and operations to increase efficiency, yields, anddecrease costs.o Participated in validation and research projects, as assigned. o Served as a senior level manufacturing associate.

o Created Scaled-down production procedures to improve efficiency and yield candidates in Monoclonal Antibody Productions. We o Carried out small-scale validation studies.o Analyzed samples generated from lab scale studies.o Managed commercial analytical method for critical points.o Developed and wrote protocols for small-scale process validation studies.o Tabulated results and completed summary of reports for process evaluation and validationstudies.o Executed cGMP activieties including Master and Working Cell Bank production.o Maintained inventory control of all cell banks produced on site.o Managed domestic and international shipments.o Participated in Tech transfer activities from development to Clinical Manufacturing.o Developed Standard Operating Procedures (SOP), Batch Records (BR), Work instructions(WI), Product Specifications (PSF) among other GMP related documentation.o Presented findings at group and interdepartmental meetings.o Maintained lab supplies and equipment.o Took ownership of manufacturing process, manufacturing support and impact assessments.o Produced and maintained accurate records.o Maintained a continuous improvement mentality, driving improvement projects to completion. o Maintained constant participation in inspection readiness as well as assistance duringregulatory inspections.o Aided in startup activities at sister site performing gap analysis, assisting in equipmentevaluation, provided training on equipment and Manufacturing standards.

o Utilized aseptic techniques, biohazard hoods and other qualified sterilized materials.o Exeprt in the preparation of C. elegans neuronal cell extraction and as well as bacterial cultures with appropriate mediums and buffer.o Isolated and quantified C. elegans RNA.o Performed primer design for rt-PCR.o Performed conversion from RNA to c-DNA using PCR.o Utilized rt-PCR to assess gene expression of certain receptors after heavy metal exposure.o Analized of gene expression using ΔΔCt Method.

o Utilized aseptic techniques, biohazard hoods and other qualified sterilized materials.o Performed mammalian and bacterial cell culture.o Developed research protocol design and execution.o Prepared C. elegans neuronal cell extraction and culture.o Assessed C. elegans neuronal cell viability after heavy metal exposure, with live/dead assay and cell counting. o Maintained cell cultures using refrigerated incubator for C. elegans cultures and CO2 incubator for mammalian cell cultures, preparation and changing of cell media and buffers.

o Utilized aseptic technique, biohazard hoods and other qualified sterilized materials.o Assessed neuronal cell viability after heavy metal exposure, with live/dead assay and cell counting. Antagonists were used to evaluate its blocking effects towards heavy metal exposure.o Maintained cell cultures using CO2 chambers, preparation and changing of cell media and buffers.