Responsible for initiating, authoring deviations for upstream and downstream processes, executing root cause investigations, driving continuous improvement efforts, implementing CAPAs plans, change controls, revising GMP documents such as SOPs and batch records for cell gene therapy products.
• Authored manufacturing deviations including root cause analysis and assessment of product impact.
• Collaborated with department managers to implement corrective actions and/or preventative actions.
• Conducted data gathering, trending and data presentation as needed to support investigations.
• Supported technical transfer process by reviewing data and monitor critical process parameters.
• Provided support for manufacturing management to meet batch record reviews and disposition schedule.

Responsible for supporting global technical operation projects for external contract manufacturing facility (CMOs) manufacturing covid vaccines. Provided oversight and guidance to the manufacturing operations (i.e., Upstream and Downstream) to support commercial covid vaccine products. Reviewed and approve key quality documents including validation/qualification documents, deviations, CAPAs, change controls, SOPs, and batch records.
• Reviewed deviations for manufacturing, analytical and supply chain and implementation of corrective actions.
• Reviewed and approve equipment/software validation protocols (IQ/OQ/PQ), i.e., Bioreactors, SCADA, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, and autoclaves.
• Served as a direct client liaison for assigned projects discussions and project updates.
• Authored protocols related to technical studies executed in direct support of GMP manufacturing activities.

Responsible for authoring investigations for deviations, non-conformances, and complaints for aseptic/sterile manufacturing for Biologic products of Emergent as an external contract manufacturing facility. Reviewed various compliance documentations i.e., SOPs, batch records, change controls, stability protocols, lab investigations, validation protocols and annual product reviews to ensure regulatory requirements and customer specifications for product release.
• Investigated non-conformances, resolved issues in manufacturing, and implementing CAPA plans.
• Authored product complaint to determine root cause, product impact and implementing preventive actions.
• Represented QA management in direct discussions with clients for assigned projects.
• Provided training for cross functional departments to continually improve manufacturing compliance.
• Identified opportunities for continuous improvement focused on quality and production.

Responsible for supporting drug product operations, and facility operations associated with the Building Monitoring Systems. Design and develop equipment upgrade for continuous improvement projects. Worked in liaison with the Quality team to author, review and approve SOPs, deviations, validation protocols, change controls and implementing CAPA plans.
• Designed and executed validation requirements for new or modified equipment leading to FAT/IQ/OQ/PQ.
• Assessed impact of change control activities for validated equipment, software, and systems.
• Performed testing of required configuration changes to the site Process Automation System (Delta V).
• Performed gap analysis on equipment and remediated gaps to ensure the cleaning program is under control.
• Monitored operational processes via using Building Monitoring System to adjust facility equipment systems.
• Developed user requirement specifications and design specifications for new equipment and upgrades.

Quality Development Program – A three (3) year corporate rotational program designed to accelerate high-potential talent through targeted training focused on Quality and Manufacturing. The rotational program associates were exposed to leadership and challenging rotations in wet, dry, and aseptic manufacturing plants in located in North Cove, NC, Bloomington, IN and Round Lake, IL.
• Authored and executed validation qualifications of critical plant equipment leading to IQ/OQ/PQ.
• Authored CSV Master Plan reviewed and approved CSV deliverables for systems as per cGMP.
• Supervised technicians responsible for providing quality oversight for manufacturing & packaging operation.
• Provided technical support to solve quality problems in product development and manufacturing.
• Participated in process and continuous improvement projects to achieve department objectives.
• Evaluated product complaint investigations and escalated Field Alert Report (FARs) submission to the FDA.

• Independently optimized, conducted and designed experimental protocol on a multifunctional coating using anodization to study the degradation of biodegradable impants.
• Presented technical reports and writing as needed pertaining to the research project.
Publication: "Effect of Mucin and Bicarbonate Ion on Corrosion Behavior of AZ31 Magnesium Alloy for Airway Stents," Materials 2014, 7(8),

• Performed corrective maintenance on equipment while generating ideas to increase reliability.
• Utilized Maximo software to evaluate stocked parts inventory for critical parts and to manage work orders.
• Established standards that reduced costs by improving methodology of tracking spare parts inventory.