Summary
Overview
Work History
Education
Skills
Timeline
Generic

Tina Atkinson

Wilton,NH

Summary

Determined and dynamic Scientist with more than ten years working as Scientist within biotechnology / pharmaceutical industry. Sharp and focused professional offering skills in Quality Control/Analytical development and Gene Therapy/Cell Therapy.

Overview

16
16
years of professional experience

Work History

SENIOR ASSOCIATE SCIENTIST (Contract)

BIOGEN, ACUTE
08.2019 - 08.2020
  • Design and develop experiments to support a small molecule drug discovery program for the treatment of stroke or epilepsy
  • Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
  • Evaluated and implemented new technologies and laboratory techniques to improve quality and robustness of sample analysis.
  • Read literature related to scientific area of expertise to remain current in knowledge.
  • Prioritized project tasks after discussions with department team.
  • Learned new laboratory techniques and applied expertise in carrying out enhanced experiments under supervision of senior lab members.
  • Performed accurate quantitative analysis of targeted data research, collection and report preparation.
  • Mouse stroke model studies to understand compound effects of stroke in mice
  • Research pertinent literature on particular studies.Clear communication and presentation of results
  • Mouse whole blood assay/ cardiac stick for blood draw/ screen potential compounds with MSD to determine cytokine levels
  • Analysis cytokine levels/determine IC50 curves
  • Ex-vivo tissue analysis for mouse PK/PD
  • Multiplexed MSD,ELISA,Western,Qpcr
  • Tissue isolation from mice and ex vivo tissue analysis
  • Analyze and present findings

SENIOR QUALITY CONTROL SCIENTIST

UNIQURE, GENE THERAPY
11.2015 - 01.2019
  • Lead method transfer of test methods for AAV gene therapy programs. Develop and write qualification and validation protocols/ reports.
  • Provide training and guidance to analysts on test methods.
  • Assist in technical writing for IND filing
  • SME qPCR, western, infectivity, ELISA assays.
  • Routine and non-routine testing of in process, final product, in accordance with standard operating procedures in a cGMP setting.
  • Procedures include Protein assays, qPCR, Potency Assay, Western Blot Quantitation, ELISA,TCID50, Cell culture, live Virus,Infectivity and DNA gel Identity
  • Develop and write protocols for equipment, new methods and special projects.
  • Lead in stability studies.
  • Assist in the management of test method assay transfer from Amsterdam.
  • Familiar with regulatory guidance’s and regulations
  • Establish, revise, review and maintain procedures for Protocols and reports.
  • Responsible for change control and deviation related to QC operations, including in with Lis, OOSs, OOTs,CCR
  • Assist with Audits and regulatory inspections
  • Trend data and aid in compilation of trend reports.
  • Communicated with production team members about quality issues.
  • Created and deployed best practices to improve efficiency and reduce defects.
  • Streamlined QA processes by working closely with development teams and staying abreast of changing product demands.
  • Noted trends in product quality and functionality to determine problem areas and plan for improvements to processes.
  • Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
  • Adhered to safety and clean area procedures to comply with agency and regulatory mandates.
  • Performed routine maintenance and calibration on testing equipment.
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
  • Conducted investigations into questionable test results.
  • Drafted technical documents such as deviation reports, testing protocol and trend analyses.
  • Liaised between quality control and other departments and contractors, providing project updates and consultation.
  • Performed cell-based potency and impurity assays for in-process, release and stability samples.
  • Maintained various instrumentation devices.

PRINCIPAL ASSOCIATE SCIENTIST (contract)

FORMA THERAPEUTICS, ONCOLOGY DRUG DISCOVERY
05.2014 - 10.2015
  • Lead discovery including cell based and biochemical assay development, and drug/target mechanism of action in the area of Oncology and other specific areas of disease
  • Develop functional assays for proof of concept and determine target engagement
  • Familiarity with oncology targets
  • Literature search; Cell Biology, Molecular Biology, Biochemistry
  • Independent assay development, analysis, trouble shooting and presentation of results
  • Study of cell pyruvate kinase deficiency. PK deficiency is the most frequent enzyme abnormality of the glycolic pathway causing non-spherocytic hemolytic anemia Developed a kinetic assay to determine the thermostability of the PK enzyme after treatment with compound
  • Study of sickle cell anemia:, developed a kinetic assay to determine the levels of 2,3-diphosphoglycerate in the glycolytic pathway and measure the effects of compounds in the reduction of 2,3,DPG
  • Experiments performed: quantitative western blot, tissue culture human cell lines, colony formation assay, SiRNA knockdown, MSD and Elisa assay development
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Conducted experiments in laboratory environment for product development purposes.
  • Collaborated with project teams to achieve data driven deliverables.
  • Maintained absolute integrity with report findings.
  • Performed intricate research within strict timeline and communicated results to project team.
  • Documented all processes during experiments, keeping meticulous notes of changes that were unexpected.
  • Read literature related to scientific area of expertise to remain current in knowledge.

QC Analyst

Shire Pharmaceuticals
12.2010 - 04.2014
  • Responsible for performing moderate to high complexity experiments requiring the application of specialized bio-analytical methods, techniques, and instruments. Assays commonly performed include Elisa’s, electrochemiluminescent plate assays using MSD system and enzyme activity assays for the support of projects in Clinical, and Post Market programs. Validation work as needed.
  • Elisa Assay for Biomarker Detection, ECL assays using MSD system, Enzymatic assay
  • Assisted in validation work
  • Application of methods and proper handling of biological specimens
  • Data analysis
  • CLIA and GLP FDA regulated environment
  • Excellent organizational skills and attention to details
  • Prepare documents of results to be sent to clinical sites
  • Developed and maintained quality assurance procedure documentation.

Research Scientist (Company Closure)

PPD Dermatology
10.2009 - 06.2010
  • Develop and implement assays for potential drug targets for the treatment of dermatological disease’s
  • Responsible for independent assay development utilizing journals, scientific and technical expertise
  • Analysis and presentation of experimental data
  • Assist lab assistants in experimental design
  • Worked with various cell lines
  • Managed, monitored and assisted in the implementation of a new IDBS data base system to record and analyze experiments
  • Determined statistical analysis and protocol design for assays that were recorded in the new IDBS data system
  • Elisa based Bio-plex for cytokine screening in cell culture,
  • Developed Assays for gene expression using qPCR
  • Implemented robotics for ABI 7300 QPCR for high throughput
  • Assay development for the effect of drug compounds on neurite outgrowth
  • Array scan imaging technology to determine the effects of a drug target on neurite outgrowth using neuronal cells
  • Assay development to determine the toxicity and proliferation of epidermis cells after exposure to a drug target
  • Performed statistical analysis on experiments, prepared reports and presented results
  • Administrator for a new data base system that was implemented
  • Responsible for protocol development and maintenance of the IDBS program
  • Assisted in the implementation of robotics and development of workflows to increase the screening of drug targets in production and to decrease cost
  • Active participant in QC work and improvement in workflow through process mapping and testing
  • With a background in high throughput experience and my qualifications as a Black Belt I assisted and directed the companies movement into a more efficient medium throughput facility to increase data output and decrease cost
  • Created SOP’s for new assays and maintained any changes with current SOP’s
  • Performed research into study topics to increase knowledge and to provide valuable contributions.

Quality Control Manager

BROAD INSTITUTE OF MIT AND HARVARD
12.2006 - 05.2009
  • Utilized highly specialized scientific knowledge and technical expertise to help design and implement projects for development of new QC methods and improved QC methods for raw materials that support the Supply and Quality Management Team, Sequencing Platform, Molecular Biology Group, and its customers
  • Established specifications, and process improvement
  • Designed key research projects to support the sabbatical system for process improvement or the development of Quality Control tests and monitored their progress and results
  • Managed Lab Technicians with the sabbatical projects and oversaw the experimental and statistical results
  • Responsible for the lab technician’s results and presentation of the sabbatical projects
  • Developed protocols for Quality Control Methods
  • Assisted in monitoring control charts to ensure all systems were and remained within its limits
  • Yellow Belt Six Sigma certification
  • Black belt in Six Sigma
  • Develop and completed projects for Six Sigma for the improvement of processes and reduction of cost in the Sequencing Group, Molecular Biology Group, Supply and Quality Group
  • Basic application of SAP
  • Statistical analysis with Jump and Minitab
  • Other duties included summarizing and presenting project results, which included writing and editing reports.
  • Developed and analyzed quality control processes and deliverables to determine present standards and establish recommended action plans.
  • Collaborated with development teams, internal customers and product line management to verify delivery of desired quality requirements.
  • Improved quality processes for increased efficiency and effectiveness.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.

Research Associate

U Mass Medical School, Gene, Expression
09.2000 - 06.2002
  • The main focus of the lab was to understand the mechanisms that regulate gene expression in eukaryotes and the role gene expression plays in human disease
  • This interest was pursued though the use of molecular Biology, Molecular Genetics, and biochemical approaches
  • Project based experimental design with various post docs on different research areas in Molecular Biology.
  • Project experimental design to the study of transcription and its activation in both vitro and in various vivo systems using yeast and mammalian cell lines to identify TAF subunits of the general transcription factor TFIID. These were cloned and studied in yeast systems and in cell culture
  • Experimental research of TAFs that are gene-selective transcription factors required for cell cycle progression
  • A project on a new transcription pathway in which deprivation of growth factor IL-3 may result in Apoptosis
  • Experiments in cell culture were performed to determine the consequences of a deprivation of IL-3 and perhaps apoptosis
  • Another area of interest was the study of splicing factors that act early during spliceosome assembly. The experiments focused on understanding how u2af binds to pre-messenger RNA and how it initiates the process of spliceosome assembly
  • Experiment skills: Quantitative Western blots, DNA sequencing and yeast clone constructs were done. Cell culture.
  • Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.

Research Associate (transferred Another Location)

UMass Medical School, Shriver Institute
01.1999 - 01.2000
  • The Program in Neuroscience focused on the Genetic causes of abnormal brain development by examining alternative splicing
  • The chosen model of study was the human tau gene, which its product is essential in the function and structure of the axon. Alternative splicing of this gene produces many products that control axonal morphology and stability. Disruption in Tau slicing results in neurofibrillary tangles
  • Experiments included cloning tau splicing factors and checking the clone by restriction digest, PCR, and sequencing
  • Once desirable clone were produced it was transfected into mammalian cos cell where the RNA was harvested and run on a western blot and sequenced
  • The harvested RNA was also tested using Cat expression system and enzyme essay
  • Developed experiments included cloning the tau gene with GFA and transfecting it into cos cells
  • The cos cells were prepared to grow on slides prior to transfection
  • Once transfected the cells were able to be detected under an Immunoflourescence microscope
  • The location of the tau gene was able to be determined


Analytical Senior Scientist

Mustang Bio
02.2021 - Current
  • Analytical design and development of molecular and biochemical assays for cellular
    therapeutics to support process development, translational and clinical development of drug
    products at all stages.
  • Developed and established a new test method for lenti-viral vector titration assay for functional and quantitative transduction.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Documented changes during experiments, noting unexpected issues arising during research activities.
  • Prioritized project tasks after discussions with AD department team.
  • 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.
  • Worked as member of integrated project team in highly collaborative work environment focused on enhancing the method transfer, qualification and validation stream flow.
  • Developed a new test method for ddPCR assay for the determination of vector copy number.
  • Potency assay development.
  • Lead on technology transfer of analytical methods to support QC and analytical method qualification and validation.
  • Support process development for new cellular therapy products.
    Author and review technical documents such as methods, qualification/validation
    protocols and reports.
  • Serve as analytical subject matter expert to solve technical challenges and support
    laboratory investigations.

Education

BA - Biology

Fitchburg State College
05.

No Degree - Biomedical Science Program

Umass Medical School

Master of Science -

John Hopkins University
01.2021

Skills

  • Experimental Design/Molecular and Cellular
  • Gene Therapy/Cell Therapy
  • Regulatory Requirements
  • Lean Principles
  • Molecular Genetics
  • Advanced Research Techniques
  • Complex Problem-Solving
  • Experimental Protocols
  • Excellent Written and Verbal Communication
  • Method Development/Qualification/Validation
  • GxP Compliance

Timeline

Analytical Senior Scientist

Mustang Bio
02.2021 - Current

SENIOR ASSOCIATE SCIENTIST (Contract)

BIOGEN, ACUTE
08.2019 - 08.2020

SENIOR QUALITY CONTROL SCIENTIST

UNIQURE, GENE THERAPY
11.2015 - 01.2019

PRINCIPAL ASSOCIATE SCIENTIST (contract)

FORMA THERAPEUTICS, ONCOLOGY DRUG DISCOVERY
05.2014 - 10.2015

QC Analyst

Shire Pharmaceuticals
12.2010 - 04.2014

Research Scientist (Company Closure)

PPD Dermatology
10.2009 - 06.2010

Quality Control Manager

BROAD INSTITUTE OF MIT AND HARVARD
12.2006 - 05.2009

Research Associate

U Mass Medical School, Gene, Expression
09.2000 - 06.2002

Research Associate (transferred Another Location)

UMass Medical School, Shriver Institute
01.1999 - 01.2000

BA - Biology

Fitchburg State College

No Degree - Biomedical Science Program

Umass Medical School

Master of Science -

John Hopkins University

Similar Profiles

CREATE PROFILE
Tina Atkinson