Principal Scientist And Principal Scientist Ii resume example with 20+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:

Experienced Industry professional with 15+ years of expertise in Immunoassay (IA), Clinical Chemistry (CC), Molecular, Core lab invitro diagnostics (IVD) development and product launches in US and Worldwide (WW).

  • Results driven servant leader with the below skill sets .
  • Technical skills:
  • Design,develop,launch Qualitative & Quantitative diagnostic assays.
  • Application of advanced Scientific Principles and knowledge.
  • Chemistry , Biochemistry, Immunology. molecular Immunology.
  • Experienced handling broad spectrum of health conditions from infectious disease, allergy, autoimmune,bioterrorism agents to cancers.
  • Clinical laboratory training and working with patients in outpatient clinics. IRB regulation's and ICH guidelines.
  • Plan, Design, execute IVD Verification and Validation/Clinical studies, studies using CLSI guidelines based on international regulations for CE mark IVDD /IVDR /FDA 510K,PMA /CFDA/PMDA and other regulatory agencies.
  • Data Collection,Analysis, trouble shooting and Problem-Solving .
  • Provide strategic initiatives and alternate cost effective solutions for trouble shooting technical issues.
  • Analytical Thinking and Technical Leadership.
  • Plan, Design and execute fundamental research.
  • Establish design specifications, Manufacturing Processes and documentation, DMRS, DHFS, Risk management, control plans and process and design FMEAS.
  • Product development with Customer centric focus:
  • Customer centric product development and translating customer. medical and regulatory requirements into Product and process requirements.
  • Technical expertise in bringing study results and claims to Package insert and trouble shooting guides, Technical Bulletins and Product information letters to customers.
  • Support global commercial,Technical Operations and Service with on market field complaints and escalations to address immediate actions to help resolve customer issues.
  • Quality and Regulatory guidelines implementation:
  • Quality by design and quality by validation for maintaining quality systems.
  • Implementation of quality system , Polices, operating procedures and forms.
  • Design plan and Quality system implementation and documentation.
  • Working Knowledge of US and International regulations and quality standards affecting IVDs.
  • Drafting and executing Design Verification and Clinical studies based on CLSI and regulatory and compliance agency-based guidelines including FDA, JPN PMDA, China CFDA, Indian Regulatory.Experienced in Designing and developing clinical studies in applying the applicable sections of regulations/Standards /guidelines for medical devices to ensure protection of human subjects and specimen and data integrity.
  • Knowledgeable in establishing design specifications, Manufacturing Processes and documentation, DMRS, DHFS, Risk management, control plans and process and design FMEAS.
  • International Product master files chapters and 510 K chapters for regulatory submissions. Obtaining and collecting the necessary documentation, designing the strategy for regulatory submission purposes, and preparing Regulatory chapters for CE IVDD and IVDR/ letters to concerned FDA authorities.
  • prepare and present quality milestone Deliverables.
  • Written and communication skills:
  • verification/validation protocols drafting & results and record documentation.
  • Publication Development,Paper Proof reading, editorial review and Report Writing.
  • Written and Verbal Communication.
  • Adept at communication and presentation to all levels of management.
  • Skilled in messaging elevations to the Elevation boards and DVPS while bringing forward alternative solutions for resources and budgets; consolidate and rationalize budget needs.
  • Identify and present needs for capital; facilities; and product and process improvements.
  • Project and Product Management :
  • Self-Driven and Motivated
  • Effective Multitasking & Time Management
  • Project Management and industry stage gating PDP process.
  • Holding stage gate reviews/ verification , validation and Product Launch reviews.
  • Product Life cycle Management from conceptualization through commercialization
  • Maintaining inventory and logistics.
  • SOP /SOW/Entity and LRP budget development resource management.
  • Budgeting and financial planning using business metrics and analytics for decisions.
  • Mentoring and teaching skills :
  • Staff Training and mentoring
  • Elementary , middle , highschool ,undergrad and medicine Student mentoring and training to build passion in STEM.
  • Effective team player with multiple global cross-functional teams.
  • Interpersonal and cross functional leadership skills and ability to identify and achieve scientific collaborations with academic, industrial research groups and Contract research organizations to complete time sensitive projects.
Principal Scientist and Principal Scientist II , 06/2015 to Current
Abbott Diagnostics, Abbott LabsCity, STATE,

Designed, Developed and Launched - Qualitative, Quantitative, and semi-quantitative IA and CC assays.

  • Technical lead PARVO B19 Ag and Ab assay development for Japanese red cross [JRC, JPN PMDA], PARVO B19 Antigen assay Launched March 2018 for JRC, in JAPAN on Abbotts Architect platform.
  • CA 72-4 [ Cancer marker 72-4 for quantitative detection and aid in monitoring of Gastrointestinal and Ovarian cancer patients, IVDD/IVDR compliant assay launched worldwide Jan 2021], on Abbotts Architect and Alinity platforms.
  • TRAb [Thyroid receptor Autoantibody to aid in differential diagnosis of Graves’ disease, IVDD/IVDR worldwide launch July 2021], launched on Abbotts Architect and Alinity platforms
  • HAVAb IgG [US FDA /510K submission Sept/Oct 2022] on Abbotts Alinity platform.
  • Worked efficiently with Abbott global cross-functional R&D and Ops teams in US, WIE, Japan, Longford, Sligo sites overcoming time and cultural barriers and with TPMS including Denka bringing assays from bench to on market. Launched 5 IVDS worldwide in a span of 7 years at ADD and ongoing efforts to launch HAVAb IgG within US
Scientist and Senior Scientist and Safety Officer, 09/2008 to 01/2014
Arryx Division Of HAEMONETICSCity, STATE,
  • Assay development and optimization, Instrument Prototype design skills: Developed and patented Immunodiagnostics for blood typing and screening. A novel cutting-edge technology used for ABO blood typing and unexpected antibody screening and identification, leading to WW patents and development of next generation diagnostic instrumentation.
  • Independently conceived, designed, and developed the feasibility of assay development and manufacturing for multiple projects.
  • Identified, purified, characterized and optimized proteins and diluents and assay conditions for developing the blood typing and screening diagnostics. Optimized product design, processes and procedures and setting specifications for scaling up and manufacturing.
  • Mentoring and Communication skills: Managed and supervised technical team, presented complex technical findings and conclusions

to internal and external audiences, staying current with scientific and industry literature, competitive technologies and products, promoting internal and external collaborations.

  • Led and mentored several technicians with SOP and protocols drafting and execution and helped build the design and verification and validation methods assay performance on prototype instrument.
  • Developed in-house SOP’s and trained junior scientists and technicians to store plasma, red blood cells and screen and identify the unexpected antibodies in plasma. Built a plasma library of rare plasmas, procuring from various blood banks across the country by networking.
  • Specimen procurement and collection and Inventory Management:Proactively built a network with blood banks across the United States to procure rare plasmas and red cells for building an in-house plasma and cells library used to develop diagnostic tests. Built a strong network with hospitals in order to perform large scale, double blinded, preclinical trials.
  • Procured human donor blood samples from blood banks to conduct pre-clinical trials manually in house to assess the test performance. Performed statistical analysis and analyzed complex data critically by applying advanced computer skills and identifying the source of variables in the test.
  • IP and Patent identification Skills: involved in identifying the patentable aspects of the technology and bringing scientific discovery to IP team. Partnered with the legal department in drafting the patent. Highlighted the uniqueness of the test developed compared to the commercially available tests to strengthen the relevant claims, performed extensive literature and database searches to exclude any infringements.
  • Quality and regulatory/ internal and external standards development and Lab safety implementation skills
  • Initiated and implemented QC by design and validation principles and also cGMP processes during bulk manufacturing of disposable immunodiagnostic. Established Communication with FDA for requirements for submission.
  • Led trouble shooting activities and identified the key components responsible for the quality control and repeatability and reliability of the test.
  • Served as the Safety Officer, required to maintain OSHA standards at workplace, performed safety and security training for blood borne pathogens and biohazard materials specimen handling, workplace injuries filing, and biohazard and chemical hazardous materials proper handling and disposal.
  • Clinical studies and External collaborations with Customers and Clinical laboratories:Performed customer surveys with blood banks for obtaining customers’ requirements [Northwestern and Uni of Chicago and Mt Sinai hospitals and physicians] for value added understanding not only from scientific perspective but also from customer need for improvising the product. Identified proper sample volumes for blood testing, applying real world use cases in order to design relevant tests.
  • Conducted external COE and Clinical studies in clinical laboratories to assess the existing limits of detection on commercially available diagnostic platforms. Identified the existing limits of detection to then translate the product requirements and establish the in-house diagnostic
  • . Budget and Finance decision making Skills: Managed an annual budget of $250,000 for instrumentation, involved in budget and resource planning and cost effectiveness and execution and people recruitment and LRP . Actively involved in recruitment of technicians and scientists.
Associate and Assistant Scientist, 06/2002 to 08/2008
Oklahoma Medical Research FoundationCity, STATE,

Developed scientific questioning, troubleshooting, grant and scientific writing communication skills as an independent contributor, while Managing Multiple projects at OMRF & OUHSC Bioterrorism consortium as a post-doctoral trainee.

Project 1: Molecular mechanisms involved in CD4/CD8 T cell differentiation

o Identified and published novel genes and potential Transcriptional regulators in CD4/CD8 T cells lineage by differential gene expressions and studying their functional significance in the lineage decisions by dissecting the signaling pathways utilizing microarray, Real time PCR. PCR and flow cytometry techniques.

· Project 2: Role of lef-1(lymphoid enhancer 1) in CD4/CD8 T cell differentiation
Identified and Cloned genes in lck driven expression lenti viral vectors in DP cells to study role of growth factors in transcription of Hematopoietic stem cell to CD4/CD8 T cell lineage choice in Egr KO mice.

· Project 3: Mechanisms of immune tolerance: Molecular basis of T cell Anergy

o Identified and published novel signal transduction pathways essential in induction and maintenance of anergy in T cells. Studied Balb/c and transgenic mice with Staphylococcal enterotoxins induced anergy model. Functional significance of the differential gene display was studied using microarray, real time PCR, FISH, flow cytometry of surface biomarkers. This was the first study to establish the potential role of Notch and Wnt members in T cell tolerance.

· Project 4: Identification of sequential B cell epitopes of recombinant Anthrax Lethal Factor (LF) and protective antigen (PA)

o Identified and published potential vaccine targets for Anthrax, a bioterrorism agent. Identified novel B cell epitopes and studied the efficacy of the recombinant vaccine with both the LF and PA antigens in protection against anthrax.

Ph.D., Immunology, 01/1997 to 05/2004
All India Institute Of Medical Sciences,AIIMSCity, STATE,

Successfully managed multiple projects with clinical laboratories, patients and AIIMS Hospitals and worked as teaching and lab assistant to MD/MS and Medicine undergrad students and mentored Junior scientists.

· Project 1: "Expression of Co-Stimulatory Molecules in Peripheral Blood Derived Monocyte, Macrophage and T Cells from Patients Infected with Mycobacterium Leprae.” Identified and Published T-cell stimulatory and immunomodulatory molecules with cytokine profiles and surface biomarker fluorescent evaluation studies in Leprosy patients utilizing isolated PBMC's, T cell and B cell and cytokine assays.

· Project 2,3,4 Identified and published efficacious vaccine and Diagnostic candidate peptides and proteins for infectious diseases HIV, Dengue, Malaria and Plague by utilizing B and T cell solid phase epitope mapping techniques in collaboration

Education and Training
Product Management Certification : Product Management , Expected in 12/2022
Kelloggs School, Northwestern University - Chicago, IL,
Certificate in Clinical And Regulatory Affairs: Clinical and Regulatory Affairs , Expected in 03/2014
NUCATS, Northwestern University - Evanston, IL,
Grants Writing And Management Training: Medical Writing And Communication , Expected in 08/2006
Oklahoma State University - Oklahoma City, OK,
Ph.D.: Immunology, Expected in 05/2004
Diploma, Systems Management : Computer And Information Sciences, Expected in 12/1996
APTECH - Visakhapatnam, India ,
Master of Science: Biochemistry, Expected in 09/1996
Andhra University - Visakhapatnam, INDIA ,
Full Professional
Native/ Bilingual
Full Professional
  • Received 15+ Excellence awards from Abbott Senior Management, CFT and Abbott President for the technical leadership skills and driving projects successfully to Launching PARVO, TRAB, CA72-4 assays and reaching milestones and meeting business needs - 2015-current
  • Received Service recognition awards for developing and mentoring, Women in STEM and Children and high School, University and pre-Medicine and Medicine students of IPSD 204, 203 in Stem Careers from Nonprofit organizations TTA. 2015- current
  • Received Abbott Presidents Award for developing and launching PARVO B19 assay for Japanese Red cross [JRC] 2018
  • OCAST fellowship for postdoctoral training (Oklahoma Center for advanced Science and Technology) 2002-2006
  • Received regional science award (in appreciation for the research on leprosy patients) in the Asian Pacific Congress for Clinical Biochemistry 2002
  • Selected as best paper of the year contest for Prof. G.P Talwar’s Young Scientist Award at the Indian Immunology Society meeting 2002
  • Awarded CSIR’s Travel grant for young scientists to attend the 11th International Immunology Congress in Stockholm, Sweden
  • Invited speaker and Best paper award in Asia Pacific Leprosy Congress 2000
  • Qualified National Eligibility test conducted by CSIR the Council of industrial and Scientific Research (CSIR), a government funded institution, for the award of JRF and lectureship Scholarship for a period of five years. 1997-2002
  • Scored in the 97th Percentile on the GATE examination conducted by Indian Institute of Technology to admit students to MS/PhD Program. 1997
Additional Information
  • Authored 5 US and WW patents and 14 international Publications of repute can be found online in Pubmed and Google scholar or orcid #0000-0002-9834-8720.

(*Note: When searching PubMed, the publications appear with Jessica K, Claire S, or Jessica Claire as the author)

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Resume Overview

School Attended

  • Kelloggs School, Northwestern University
  • NUCATS, Northwestern University
  • Oklahoma State University
  • Andhra University

Job Titles Held:

  • Principal Scientist and Principal Scientist II
  • Scientist and Senior Scientist and Safety Officer
  • Associate and Assistant Scientist
  • Ph.D., Immunology


  • Product Management Certification
  • Certificate in Clinical And Regulatory Affairs
  • Grants Writing And Management Training
  • Ph.D.
  • Diploma, Systems Management
  • Master of Science

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