Rita Kim L. Email & Phone Number

Alameda, California, US

Emeryville, California, US

For a Phase I/II immuno-oncology and immunotherapy company utilizing adenovirus vector and lipid-nanoparticle vaccines, reviewed, dispositioned, and acted as quality SME for the plasmid and mRNA Drug Substance manufacturing process. Managed Deviation and CAPA program for manufacturing site, including weekly tracking meetings and quarterly KPI presentation.

Leverkusen, North Rhine-Westphalia, DE

• For a pharmaceutical biologic product line, lead multi-discipline teams to investigate deviations and evaluate interactions between potential causes, test results, process/equipment changes, and process variables..
• Successfully managed a year long multi-departmental deviation trend investigation which involved a production shutdown of all product lines, daily multi-level update meetings, Batch Reportability Assessments.
• Devised and composed responses to audit observations to meet regulatory requirements with minimal production impact; negotiated with multiple departments at various levels to adjust agreements as required for.
• Drafted master comparison document of regulatory release commitments, which expedited reviews for conflicts with current release specifications

Union City, CA, US

• Coordinated and compiled regulatory submissions for product registrations and licenses for medical device instrumentation and assays. Maintained clinical documentation in FDA inspection ready status.
• Assembled and composed a master product registration catalog, which expedited review by auditors, manufacturing, and distribution.
• Coordinated the response to questions by the Korean MFDS regulatory body regarding IVD instrument and assay medical device approval submission.

• As Project Manager of an update of Celera’s flagship product, prioritized, allocated, and tracked objectives and deliverables using MS Project. Following strict cGMP FDA and ISO regulations, planned and performed.
• Conceived, developed and presented an alternate test method validation path which reduced the project completion time by 6 weeks
• Identified potential raw material creation error, which reduced future planning conflicts
• Investigated and isolated the cause of failing reverse transcriptase experiments, which saved the cost of qualifying a new raw material vendor

• Following strict cGMP FDA and ISO regulations, tested a wide range of product lines, revised procedures, and investigated non-conformances for root causes. Wrote and executed engineering and validation studies for.
• Initiated and coordinated the validation of decreased pre-screen testing for a raw material, which reduced quality control testing time from 12 weeks to 6 weeks
• Negotiating with an outside vendor, proposed and created an online database for external testing reports, which eliminated hardcopy filing and increased efficiency
• Leveraging familiarity with multiple departments, devised an alternate label validation path which reduced project completion time by 3 weeks
• Devised and validated an alternative quality control testing scheme for a new product line, eliminating at least one hour of manufacturing downtime per build or approximately 40 man-hours per week
• Evaluated and presented analysis of QC utilization hours which disproved a decrease in testing efficiency and helped reduce production backlog by providing increased QC staffing

Hercules, CA, US

• Tested a wide range of product lines following ISO 9001 requirements. Coordinated with multiple departments to validate and revise QC procedures for three new product lines
• Trained two new chemists on procedures and standard protocols

• Manufactured IVD diagnostic kits following strict cGMP FDA and ISO regulations
• Earned the first ever 0% document error rate for fiscal year 2007, which expedited record review and product release time
• Created master document of manufactured hazardous waste and their classifications, which increased safety and reduced hazardous waste label creation time

Berkeley, CA, US

• Characterized anaerobic bacteria using techniques such as DNA extraction and microarray analysis
• Assisted in biomass production and remediation experiments, managed testing results
• Prepared media and stock solutions, organized and maintained laboratory, monitored and reordered supplies

Bachelor'S, Molecular And Cell Biology

Master Of Business Administration (M.B.A.), Concentration: Finance; Leading People And Organizations

Master Of Business Administration - Mba