Mina S. Bentil, MBA

ad2lu1@r.postjobfree.com

Germantown, MD • 301-***-****

Summary

Contract Research Organization; Quality Control/Assurance & Compliance Management

Versatile manager with extensive leadership experience in a high growth company across contract research organization, biotechnology and pharmaceutical.

Proven success spearheading multiple complex and effective projects according to strict deadlines. Demonstrated ability to write protocols, documents, Standard Operating Procedures (SOP), Out of Specification (OOS), Deviations and Corrective and Preventive Actions (CAPA) in line with FDA regulations. Knowledgeable and follow Quality Management Systems (QMS). Familiar with ISO 9001:2015, ISO 13485:2016, 21 CFR Part 11 and with FDA and GCP requirements. Adept at conducting routine and non-routine analysis of raw materials as well as investigating out-of-trend results, specifications, and non-conformances. Very conversant with Lean and Six Sigma practices and methodologies. Highly skilled at promoting teamwork and effective communication to develop productive relations with clients and coworkers. Extensive involvement in both internal and external Audits.

Areas of Expertise

•Internal & External Auditing

•Operations Management, QMS

•Spiking & Run Assays

•Technical Support; Lean Six Sigma

•Aseptic Techniques

•Compliance GMP, GLP, GCP

•QC Testing & Documentation

•Data Collection & Validation

•Scientific Research Methods

•Qualitative/Quantitative Analysis

•Team Building & Training

•Budget Administration

•Records Administration

• Product Inspection

•Vendor Relations & Tech Support

Accomplishments

●Excellent and conversant with impromptu external audits by FDA, ISO and/or Clients

●Effective oversight and knowledgeable with Quality Management Systems

●Developed and implemented exceptional laboratory aseptic techniques with minimal analyst errors.

●Accurate in spiking technique; Unerring patient Sample Analysis, Stability and Validation Runs.

●Quality Compliance and Audit readiness for internal and external Auditing; knowledge of Lean and Six Sigma

●Known as monthly auditor for quality control labs at Roche Molecular Diagnostics for internal audits.

●Earned Spot Award for performing extra out of regular duties in an efficient manner.

●Received recognition from manager for troubleshooting one assay by identifying the root cause and conducting experiments on all areas.

●Multifaceted in quality control, assurance, and compliance for diverse sectors such as CRO, Biotech, Pharma and Healthcare.

Career Experience

Associate Research Scientist, Smithers, Gaithersburg 2021-2023

Implementation of spiking schemes from Analytical plan and Standard Operating Procedure (SOP) alongside specified assay Methods; execute performance and release Anti-Drug Antibody (ADA), Pharmacokinetic (PK) and Neutralizing Antibody (NAb) assays. Pick patient samples from secured sample management database (Watson), verify samples by a second Analyst before execution of assay.

●Routine process of using Ligand Binding Assays (LBA) to detect and quantify biotherapeutics, biomarkers, and anti-drug antibodies in biological matrices

●LBA measures the interaction between two molecules or the binding of molecules to antibodies, receptors, and other large complex molecules

●Utilize Meso Scale Discovery (MSD) to execute ADA, PK and NAb assays. Occasional usage of M3 to analyze assays

●Create spiking schemes for large samples analysis, long-term stability (LTS) or fresh spikes for ready to use assays.

●Validation and cross-validation of new Methods and existing methods; very detailed documentation and verification of samples in sample analysis and validation.

●Quality Control for Run folders, Reagent Preparation Forms, Notebooks and Shipment folders

●Continuous laboratory readiness for internal and external scheduled or unscheduled audits

●Cross trained and support departments like Quality Control in proper Shipment documentation and Sample Management assortments of Patient Samples and logging into the software storage in Watson.

●Implementation of Lean and Six Sigma methodologies

Quality Control, Scientist 1, QIAGEN, Germantown 2012 – 2021

Hold full accountability for performing and releasing detailed assays at a limited time as well as reviewing and writing SOPs. Gather samples from manufacturing purified water system and conduct Bioburden testing. Carry out inspection on company products as well as automated/manual QC testing on HPV/CT/GC assays using different platforms.

●Experienced Scientist in the knowledge and practice of Lean and Six Sigma methodologies

●Utilized Salmon Sperm Genomic DNA and Plasmid Capacity to check the quality of filters in the columns.

●Used Fourier Transform Infrared Spectroscopy (FTIR) to detect alcohol concentration in buffers and identify guanidine hydrochloride and Guanidine thyocynate in chemicals.

●Identified need for skills improvement and conducted regular training sessions for numerous scientists that improved overall work efficiency.

●Ensured accurate diagnosis and swift resolution of all technical problems.

Molecular Labs, Scientist 1, Co-Trainer, Lab Support Trainer, QIAGEN, Germantown 2008 – 2012

Executed pH and conductivity test on company buffers as well as density test on water samples and solutions. Headed and supervised analysts on SOP review training and documents. Learnt various company platforms and testing. Accomplished all lab work and released assays for quality control purposes.

●Set a new benchmark for excellence by leading a project associated with validation of final kit QC.

Previous Experience, Quality Control Scientist 1, Roche Molecular Systems, Branchburg New Jersey 2001 – 2008

Initially hired for Molecular Labs Analyst II, Aerotek Scientific, Temporal Agency, later transitioned into Quality Control/Operations, Scientist 1 with responsibilities of routine testing of the qualification and quantitation of infectious diseases such as HIV, HPV, CMV of individual buffer components and assembled kits using Roche instrument platforms. Co-Trainer, Lab Support Trainer.

Additional Experience, Rutgers the State University of New Jersey Cook College New Brunswick NJ 1997 – 2000

NJ Research Intern, USDA, Rutgers Summer Research Program, Human Research Department Cooperative Education, Plant Tissue Culture Research Assistant, Rutgers University Department of Plant Science, New Brunswick, NJ

Summer Program Participant, UMDNJ Biomedical Careers Program Level II, New Brunswick, NJ

Voluntary Work

Adaptable personnel for multiple tasks at The Master’s Holy Mountain Embassy

Humanitarian work using my CNA Certificate,

Qiagen Inc., Stepping Stone Shelter,

Active Young Adults Guild, Secretary

Cook College Leadership, Steering Committee Member

Minority Education of Cook College Alliance, Lab Assistant

Education

Master of Business Administration (MBA) in General Management

Keller Graduate School of Management, Long Island, NY

Bachelor of Science, Major: Biotechnology, Minor: Biochemistry

Rutgers the State University of NJ (Cook College), New Brunswick, NJ

Technical Proficiencies

Meso Scale Discovery (MSD), M3, Watson, Mosaic, PCR, Cobas Amplocor™ Analyzer, SAP 710, Master Control, LIMS, iPOST v3.0, Amplilink, Milliflex, QuantiFERON® ELISA, Endotoxin, Kinetic Turbidimetric, Rapid Capture System

Mettler Seven Multi pH/Conductivity Meter, Mettler Toledo DE40 Density Meter, Lean, Six Sigma, Microsoft Office/Teams/Excel/Powerpoint

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