Carol-Ann Hankins
Arcadia,CA
Summary
Determined and well-rounded individual with more than 20+ years working as a Scientist in the Biotech industry & Clinical Laboratory Scientist within Clinical laboratories in Molecular Biology, Gene Therapy assays, Cell Culture, Genetics, HLA, Bloodbanking & Lab Safety. I also have 8+ years of Supervisory experience. Trained on the latest molecular biology platforms & assays including BioRad’s QX200 & QXOne ddPCR systems, CellCelector, Stratagene II, Illumina’s MiSeq, Sequenom, Affymetrix, ABI Genetic Analyzers & 7900HT, Megabace, Lightcycler, NanoDrop, Autogen, Tecan Robotic Systems, Caliper, Bioanalyzer, QIAcube & MagnaPure. My research projects led to 5 scientific publications, one in the Human Mutation journal, making me a valuable asset to any research team. Proven ability to design and implement large scale projects with outstanding leadership, training, presentation, communication & administrative skills. Adept at drafting assay qualification plans & reports, Standard Operating Procedures (SOP’s), Work Instructions (WI’s) and instrument qualification/validation protocols. Able to liaise between technical and non-technical persons. Experienced at setting up several labs for CAP, CLIA & ASHI accreditation. Adept at implementing new protocols to achieve higher laboratory standards, saving time and money. Highly motivated with outstanding writing and interpersonal skills. Ready to join a new organization collaborating with other professionals in a laboratory environment.
Overview
20
20
years of professional experience
Work History
Scientist
CSL Behring
10.2023 - Current
- Developed the CFU-ddPCR assay for the Wiskott-Aldridge project which provides quantification of average lentiviral vector copies per transduced cell as well as percentage of vector-positive CFUs
- Drafted the Qualification Plan and the execution of this qualification with 4 operators
- Also drafted the assay SOP, all instrument SOP’s for GxP validation, Data Collection Forms (DCF’s), WI’s & collaborated & developed spreadsheets for molecular assays.
Associate Scientist
CSL Behring
03.2020 - 10.2023
- Participated in Phase 3 product development of HEMGENIX (first gene therapy drug for Hemophila B) and authored the validation report, submitted to the FDA for approval for one of the assays.
- Worked with cross-functional project teams to support productions of [Type].
- Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
- Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
- Led training sessions on lab equipment usage for new hires, promoting a culture of continuous learning within the team.
- Developed and validated analytical methods to ensure accurate results in various assays.
- Mentored junior scientists, providing guidance on experimental design and data analysis.
- Implemented quality control measures throughout the experimentation process to ensure the integrity of study outcomes.
- Evaluated novel materials or reagents for potential use in research projects, supporting informed decision-making within the team.
- Optimized laboratory processes by implementing new techniques and technologies to increase efficiency.
- Troubleshot instrumentation issues, ensuring minimal downtime for critical experiments.
- Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
- Enhanced team productivity by streamlining workflows through process improvements and automation solutions.
- Conducted experiments in laboratory environment for product development purposes.
- Authored technical reports and manuscripts, clearly communicating complex scientific concepts to diverse audiences.
- Played an active role in recruitment activities such as candidate screenings and interviews, helping build a strong science team for the organization.
- Collaborated with cross-functional teams for successful completion of projects, meeting deadlines and objectives.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Trained and supervised junior technicians in laboratory protocols.
- Participated in lab meetings and project presentations.
- Developed new protocols and improved existing laboratory processes.
- Troubleshot and resolved equipment and process issues.
- Collaborated with researchers and scientists to design and execute experiments.
- Analyzed results using analytical software and created reports.
- Coordinated and managed laboratory projects and experiments.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Monitored and documented safety standards to verify compliance.
- Recorded and analyzed data to produce reports of results.
- Assisted scientists by collecting and organizing laboratory data.
- Operated and performed preventative maintenance on laboratory equipment and instruments.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Participated in research projects by designing and executing experiments.
- Set and oversaw quality assurance guidelines for laboratory work.
- Provided support and guidance to junior lab staff.
- Cooperated with other technicians to develop and test new protocols.
- Interpreted laboratory results to provide technical advice to scientists.
- Kept abreast of current industry, scientific and regulatory developments and issues.
- Established assays and testing workflows for cell and vector product release (GMP), routine characterization (GLP) and patient sample analysis (GCLP)
- Supported cell product process development and pharm/tox studies
- Evaluated and updated analytical platforms, methods, and workflows to improve efficiency and quality
- Provided support for patient sample analysis (GCLP) for Phase 1 clinical trials
- Assays performed included Nucleic Acid extractions, Droplet Digital PCR (ddPCR), RT-ddPCR, qPCR, RT-qPCR &% Transduction in CFUs, conforming to GxP and GMP standards and regulations.
Lead Medical Technologist
Northwestern University’s Transplant Immunology Lab
05.2015 - 08.2019
- NGS HLA typing using MiSeq; Validation of KimerDX assays (qPCR); DNA isolation using BioRobot; HLA Sequence Based Typing; STR assays using the Promega PP21 kit; Ordering and inventory of lab supplies; Drawing up lab schedules; Reviewing results & compiling reports for sign off by Lab Director; Interviewing potential new employees; QA committee chairperson
Research Technologist 3
Northwestern University’s Genomics Core Facility
02.2013 - 05.2015
- Successfully set up the DNA Extraction Lab for CAP accreditation within 4 months & set up Sequenom SNP Genotyping & Methylation service within 1 month; Illumina Gene expression assays with iScan; DNA & RNA quantitation on Nanodrop; DNA & RNA Quality Control using Bioanalyzer; Sanger sequencing using ABI 3730 & RT-qPCR using the ABI 7900.
Laboratory Supervisor
University of Chicago’s Genetic Services Lab
10.2010 - 01.2013
- RT-qPCR with SYBR Green assays; Designing primers for sequencing & RT-qPCR; Sequencing using Mutation Surveyor; Copy number quantification & methylation using MLPA kits from MRC-Holland; UGT1A1 testing using PCR & RT-qPCR; NGS using MiSeq; Introduced AmpflSTR Identifiler kit for MCC; Implemented DNA isolation from tissue, amniotic fluid & CVS using Puregene DNA isolation kit; Overseeing CAP & CLIA for the lab; Ordering & inventory of all lab supplies.
Education
Bachelors in Biomedical Technology -
University of Johannesburg, South Africa
National Diploma in Medical Technology -
CPUT, Cape Town, South Africa
Certificate in Computers -
Access Computer, Cape Town, South Africa
Skills
- ddPCR on BioRad QX 200 & QX ONE
- DNA & RNA Extraction on QIACube
- qPCR on 7900HT & Stratagene II
- Cell Culture techniques
- DNA & RNA Quantitation on Nanodrop
- VCN by ddPCR
- RT-ddPCR
- Illumina SNP Genotyping
- Illumina Gene expression assays
- Illumina Methylation assays
- NGS using MiSeq
- RNA Quality Control on Bioanalyzer
- QA Chairperson & Lab Safety Officer
- Sequenom SNP Genotyping Assays
- MLPA techniques
- Sequenom methylation
- Setting up labs for CAP/CLIA certification
- Bloodbanking
- Quality Assurance, QC & QI
- Lab Supervisor
- HLA Typing & Chimerism assays
- Designing primers
- Sanger sequencing
- Authoring SOP’s, WI’s, Qual Plans
- Laboratory techniques
- Research and experiments
- Safety processes and procedures
- Assay development
- Research methods
- Results Analysis
- Experimental design
- Quantitative skills
- Spectroscopy Techniques
- Effective Multitasking
- Report Preparation
- Flow Cytometry (observation)
- Proficient in QuantaSoft, QX Manager
- Genomic Analysis
- Team Collaboration
- Clinical drug trials
- Routine Laboratory Operations
- Process Development
- Molecular Biology
- Molecular Bench Work
- Multitasking
- Organizational Skills
- Adaptability and Flexibility
- Task Prioritization
Accomplishments
- Successful validation report submission of HEMGENIX (first gene therapy Hemophilia B drug) to the FDA.
- Used Microsoft Excel to develop ddPCR analysis spreadsheets.
Affiliations
- American Society for Histocompatibility and Immunogenetics (ASHI) 14888
- Health Professionals Council of South Africa (MT 6058)
- The Society of Medical Laboratory Technologists of South Africa
Scientificpublications
- Novel PRG4 mutations underlie CACP in Saudi families, Human Mutatation, 2006 Feb, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16429407&query_hl=1&itool=pubmed_docsum
- Association of the Platelet Glycoprotein Receptor IIIa (PIA1/PIA1) Genotype with Coronary Artery Disease in Arabs, Blood Coagulation and Fibrinolysis, 2004, 15, 1, 77-79
- Prevalence and role of MTHFR 677 CT and 1298 AC polymorphisms in Coronary Artery Disease in Arabs, Archives of Pathology and Laboratory Medicine, 2003, 127, 1349-1352
- Prevalence of the 20210 G A Prothrombin variant and its association with Coronary Artery Disease in Middle-Eastern Arab population, Archives of Pathology and Laboratory Medicine, 2002, 126, 9, 1087-1090
- Lack of association of Lipoprotein Lipase gene polymorphisms with coronary artery disease in Arab population, Archives of Pathology and Laboratory Medicine, 2002, 127, 597-600
Scientificpresentations
- First GCC Genetics Conference, Bahrain, Localization of genes for a novel disease characterized by Congenital Intestinal Lymphangiectasia (CIL)
- KFAFH, Jeddah, Saudi Arabia, HLA typing
- World Congress of Medical Technology, Hong Kong, DNA based HLA Class II typing in transplantation
- World Congress of Medical Technology, Hong Kong, An evaluation of PCR based HLA Class II typing techniques
- National Society of Medical Laboratory Technologists, Johannesburg, South Africa, DNA isolation from whole blood for routine testing
Previousworkexperience
Authoring protocols including DNA extraction, Fragile-X testing, MLPA, Sequencing & Genotyping, all equipment protocols & all safety manuals. Operating, maintaining, troubleshooting, ordering supplies & training staff on: Illumina Beadlab Series 1000 – Infinium II Assay using automated Tecan robotic systems; Genvault Dynamic and Personal Archive; ABI DNA Analysers using Genemapper, Sequencing Analysis & DNAStar software, LightCycler; Affymetrix GeneChip microarray technology; ABI Prism 7900HT – real-time PCR; QIAcube; ND-1000 Nanodrop & ND-3300 Fluorospectometer Sequencing & genotyping on Megabace 1000; Cas-1200 Robotic System; MagNa Pure LC; Safety Officer; Drafted Laboratory Safety Manual, Chemical Hygiene Plan, Exposure Control Plan and Internal & External Disaster Plan. Research projects included homozygosity mapping for gene localisation on DNA samples from multiple large Saudi families affected with a variety of disorders including neurodegenerative, connective tissue, endocrine & metabolic. And whole genome SNP genotyping on a family with cataracts as well as families for the international autism project.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Work Preference
Work Type
Full TimeWork Location
RemoteHybridOn-SiteLanguages
English
Bilingual or Proficient (C2)
Afrikaans
Bilingual or Proficient (C2)
Interests
Sports, cooking, dancing
Timeline
Scientist
CSL Behring
10.2023 - Current
Associate Scientist
CSL Behring
03.2020 - 10.2023
Lead Medical Technologist
Northwestern University’s Transplant Immunology Lab
05.2015 - 08.2019
Research Technologist 3
Northwestern University’s Genomics Core Facility
02.2013 - 05.2015
Laboratory Supervisor
University of Chicago’s Genetic Services Lab
10.2010 - 01.2013
Bachelors in Biomedical Technology -
University of Johannesburg, South Africa
National Diploma in Medical Technology -
CPUT, Cape Town, South Africa
Certificate in Computers -
Access Computer, Cape Town, South Africa
Similar Profiles
Amy RuppAmy Rupp
Associate Director, Adaptive Clinical Trial Technology at CSL BEHRINGAssociate Director, Adaptive Clinical Trial Technology at CSL BEHRING
Melissa DaughertyMelissa Daugherty
Associate Director R&D Management at CSL BehringAssociate Director R&D Management at CSL Behring
JAMES MEEKS JR.JAMES MEEKS JR.
Hospital Sales Specialist at CSL Behring King of Prussia, PAHospital Sales Specialist at CSL Behring King of Prussia, PA
JOHN JARRETTJOHN JARRETT
Area Sales Manager at CSL BehringArea Sales Manager at CSL Behring
Jason LiJason Li
Right At School at Amber AustinRight At School at Amber Austin