Quality Control Process Development

Sharolin Sarkis

OBJECTIVE: https://ad8qz0@r.postjobfree.com/com in/sharolin-(209) 606-sarkis-1929 2674611a1/

• Analytical process developer with 4+ years of experience in process development, quality control and leadership. Skilled in data analysis, regulatory compliance, technical skills and lab research. EDUCATION

• California State University, Bakersfield Bachelor of Science, Biology May 2020 GPA:3.5

• Minor in Physics and Chemistry

• Yale School of Management; Certificate, Women’s Leadership Program September 2023 RELATIVE SKILLS

• Team leadership, business Development, Process Improvement, Project management, Six Sigma, Innovation

• Microsoft office, Adobe, R programing (analysis work), Bryce, SAP, Teams

• Experience with flow cytometry, HPLC, Automation lab system including Liquid Handler, Beckman Access Laboratory Workstation, Plate Washer and Plate reader,ddPCR

• Support CMC, stability, and comparability studies, CDMO cell therapy production, manufacturing problem solving, critical thinking, Ability to work independently and as a team member, self-starter, ability to work with minimal supervision and in fast-paced work environment, effectively communicate and collaborate across departments.

• Safety Champion, program and Project Lead, perform continuous improvement of lab processes and member of 5S

• Transfer knowledge and training, procedure development (SOP, PNS), preparing KPI reports, and technical reports

• Buffer and media formulations and preparation, cell culture passage, thawing and cryo-preserving RELEVANT EXPERIENCE

Biomedical Process Development Associate (Analytical Development) Mar 2022-Present Miltenyi Biotec, San Jose, CA

• Perform a broad range of immunology base assays on CAR T cell, monocytes and macrophages focused on process development, client project report, quality standards, validation,

• Calibration, compensation and routine maintenance of equipment and lab, restock consumables and lab supplies

• Execute performance qualification and engineering run for NDA, and Transfer knowledge and training

• Performance of flow cytometry to evaluate extensive T cell Phenotyping assays (T Stem Cell Memory, Memory differentiation, Proliferative ability, Exhaustion, Activation, CD4 Memory differentiation, Chromatin Remodeling)

• Safety Champion, program and Project Lead, perform continuous improvement of lab processes and member of 5S

• Transfer knowledge and training, procedure development (SOP, PNS), preparing KPI reports Laboratory Technician II August 2020 –Mar 2022

The Wine Group, Ripon, CA

• Supervised lab operations and Scheduling during swing and grave shifts, overseeing employee training, attending meetings, and making decisions regarding production line approval, proficient in root cause analysis and skilled in prioritizing task to streamline workflow

• Perform routine analysis at all stages of the winemaking process

• Operate and assist maintaining the laboratory instruments such as HPLC, Autotitrator, DMA, NIR, Spectrophotometer, Turbidity Meter, GC, Atomic Absorption Spectroscopy, Y15 enzymatic, Refractometer, Carbox, Aeration Oxidation, RIPPER (Titration), Serial Dilution, Filtration, Use of Centrifuge

• Record and Input data, run reports, access data, evaluate data, and recognize trends

• Performing quality check validation, calibration, and adjustment to confirm the accuracy of analysis

• Knowledge of response plan for out of specification analysis and help streamline the workflow

• Assist with training to ensure team members are appropriately trained to perform job tasks

• Sample management, coordination with other department for sample delivery and storage

• Lead of inventory management completing purchase order request, restock supplies and maintain inventory of critical reagents and materials, preparation of standard laboratory solutions.

• Safety SME and Project Leader, perform continuous improvement of lab processes and member of 5S auditing and inspecting lab, promoting safe work habits.

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