Kim Foster

Kim Foster Email and Phone Number

Foster Scientific , Inc @ Verity Group
Boylston, MA, US
Kim Foster's Location
Boylston, Massachusetts, United States, United States
Kim Foster's Contact Details

Kim Foster personal email

Kim Foster phone numbers

About Kim Foster

Kim Foster has a PhD in Biochemistry and has been working in the biotechnology field for the past 30 years. Her background is diverse having worked in diagnostics, biologics, and pharmaceutical development. She has held many positions where she has lead teams for the development and transfer of products to manufacturing. She has even run a small animal facility which performed pre-clinical animal studies for GLP projects. She has a broad background in the development of GMP & GLP assays for in- process, final product release testing and for subsequent clinical trial use. Since 2007, she has been a consultant supporting analytical assay development, validation, CMC support and documentation and ICH Stability. With her broad background she has overseen and coordinated the activities of CROs and CMOs for Sponsor companies. She has expanded her prior analytical experience to include QA, GxP documentation systems and GXP auditing. She has supported FDA submissions by providing review and written work for multiple 510Ks, PMA, IND, BLA, IMPD and NDA filings for pharmaceutical and diagnostic products.

Kim Foster's Current Company Details
Verity Group

Verity Group

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Foster Scientific , Inc
Boylston, MA, US
Website:
verity.com.br
Employees:
185
Kim Foster Work Experience Details
  • Verity Group
    Verity Group
    Boylston, Ma, Us
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  • Voyager Therapeutics,
    Glp Auditor
    Voyager Therapeutics, Apr 2022 - Present
    Perform three site audits Voyager for CRO facilities April, May 2023 and January 2024
  • Gt Biopharma, Inc.
    Quality Control, Gmp Support
    Gt Biopharma, Inc. Jan 2022 - Present
    • CMO method SOP and method qualification review • Batch Record Review and Reports, SOP, etc. review for the CMO Site
  • Synspira Therapeutics
    Quality Assurance, Technical Writing Support Consultant
    Synspira Therapeutics Sep 2020 - Present
  • Self-Employed
    Consultant, Foster Scientific Inc
    Self-Employed May 2007 - Present
  • Novabioassays
    Qa Manager, Consultant
    Novabioassays Jun 2016 - Present
    • QA Manger for the site.• Assist NBA with QA system set up. • Perform all internal and external audits for the company.• Set up systems to allow company to move into GLP compliance.
  • Cellarity
    Qa Systems Documentation And Gcp Validation Consultant
    Cellarity Jan 2021 - Dec 2021
  • Kaleido Biosciences
    Qa/Qc Consultant
    Kaleido Biosciences Jul 2018 - Dec 2021
    Lexington, Massachusetts, Us
    Work with QA to create a QC SOP system, work with Pilot Plant to set up a GMP system, Batch record review.
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  • Apellis Pharmaceuticals,
    Technical Writing Support Consultant
    Apellis Pharmaceuticals, May 2021 - Aug 2021
    Assist in the writing and editing development reports
  • Oxeia Biopharmaceutical
    Technical / Cmc Consultant
    Oxeia Biopharmaceutical Nov 2019 - Dec 2020
    Provide technical review, and support for CMC
  • Cell Assay Innovations
    Qa Consultant
    Cell Assay Innovations Aug 2019 - Aug 2020
    Assist in bringing the lab to GLP compliance. This includes: training, gap analysis of lab, insuring QA system in place, reviewing assay validation and acting QA reviewer on data.
  • Allena Pharmaceuticals, Inc.
    Techincal Writer Consutlant
    Allena Pharmaceuticals, Inc. Jul 2019 - Feb 2020
    Newton, Ma, Us
    • Draft/Author Technical Documents related R&D activities• Draft /Author SOPs and work instructions for lab equipment and test methods.
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  • Criterion Biotech Consultants, Waltham, Ma
    Consultant
    Criterion Biotech Consultants, Waltham, Ma Dec 2017 - May 2019
    QA/ Analytics and Technical Writer Consultant• Coordinate and review work performed at CROs to support NDA filing. • Ensured work was scientifically accurate and delivered in a timely fashion• Prepared scientific documentation for NDA filing as needed.
  • Consultant Through Biobridges Sarepta Therapeutics
    Consultant Clinical / Technical Writer Consultant/ Qa Auditor
    Consultant Through Biobridges Sarepta Therapeutics Oct 2014 - Mar 2018
    QA GLP Consultant/ Auditor (as requested)• Perform site audits of GCP/GMP/GCP facilities, as requested.• Assist sites to set up GLP documentation systems.
  • Pharmalex
    Qa Consultant
    Pharmalex Mar 2016 - Jan 2018
    • Program Management of the GCP site for the specific clinical trial• Perform site audits of /GCP/GMP/GCP facilities as requested.• Assist sites to set up GLP documentation systems and basic support system to allow GCP clinical trials studies to be performed• Oversee testing/auditing of LC-MS GLP studies at a CRO for clinical studies.• Assisting young staff to set up a GLP complaint system at their analytical testing facility
  • Agilux Laboratories, A Charles River Laboratories Company
    Qa Consultant
    Agilux Laboratories, A Charles River Laboratories Company May 2016 - Nov 2017
    Work with the QA group to perform a wide variety of audits across the company. Audits include: internal and external audits for: laboratory, facility, documentation, metrology etc
  • Consultant Through Biobridges Stealth Biotherapeutics
    Consultant: Cmc Stability Coordinator And Analytical Chemistry
    Consultant Through Biobridges Stealth Biotherapeutics Aug 2014 - Mar 2016
    Needham, Massachusetts, Us
    CMC Coordinator for the Drug Substance and Drug Product Stability program: oversight of all CRO data, import and review of all data, writing of reports, SOP, and statistical analysis of data.Provide analytical support when needed, to include review of documentation and methodologies.• Manage multiple Drug Substance and Drug Product programs, data review, report and regulatory submission writing, and data analysis. • Extrapolations of stability data to determine retest and expiry periods. Extrapolate development stability data to predict retest and expiry times.• Review stability protocols, data reports, and final reports. • Coordinate review with Quality Assurance. Manage stability programs at multiple vendors. • Write stability-related reports and CMC sections for regulatory submissions.
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  • Ironwood Pharmaceuticals
    Qa Glp Consultant (Through Biobridges Inc)
    Ironwood Pharmaceuticals Apr 2014 - Sep 2014
    Boston, Ma, Us
    QA liaison to work with Pharmaceutical Development (PD) to establish an internal GLP testing program. Write the pertinent SOPS required, set up lab requirements and instrumentation documentation, work closely with PD to reach aggressive time line (6 weeks) to go from R&D to GLP. Audit system post launch of GLP program.
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  • Allena Pharma
    Consultant
    Allena Pharma Jan 2012 - Jun 2014
    Preparation of scientific documentation for NDA filing for pharmaceutical company to include: preparation of technical reports, method protocols, SOPs, retrieval, evaluation and analysis of primary data from notebooks and contract laboratories. Support the Contract laboratory day to day basis on technical level with experimentation.
  • Alcresta Pharmaceuticals
    Consultant
    Alcresta Pharmaceuticals Jan 2012 - Jun 2014
    Preparation of scientific documentation for NDA filing for pharmaceutical company to include: preparation of technical reports, method protocols, SOPs, retrieval, evaluation and analysis of primary data from notebooks and contract laboratories. Support the Contract laboratory day to day basis on technical level with experimentation
  • Blue Bird Bio
    Consultant
    Blue Bird Bio Jan 2012 - Mar 2013
    Consultant to QA in support CRO data and documentation. Support to clinical program and work with the CRO to set up the clinical testing program.
  • Synta Pharmaceuticals
    Qa, Glp Auditor Consultant
    Synta Pharmaceuticals Mar 2009 - Jun 2011
    • Act as a liaison between QA and the Bioanalytical Scientific staff to improve communications and provide a better understanding of the science for the QA side.• Audit and review clinical trials data from the Bioanalytical group. • Perform In-Lab Audits
  • Agilux Systems Inc.
    Consultant To Qa
    Agilux Systems Inc. Aug 2010 - Dec 2010
    GLP auditor for the Bioanalytical division for the Quality assurance department.
  • Alnara Pharmaceuticals, Inc.
    Consultant, (Sub Contact To Criterion Biotech Consultants)
    Alnara Pharmaceuticals, Inc. Jun 2009 - Sep 2010
    Us
    Preparation of scientific documentation for NDA filing for pharmaceutical company to include: preparation of technical reports, method protocols, SOPs, retrieval, evaluation and analysis of primary data from notebooks and contract laboratories.
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  • Immuneworks, Inc., Indianapolis, In
    R&D Consultant
    Immuneworks, Inc., Indianapolis, In Jun 2009 - Sep 2010
    • Support bioanalytical test method development and validation, to support clinical trials.
  • Smart Cells
    Consultant
    Smart Cells Feb 2010 - Aug 2010
    Assist bio analytical group in the validation of their ELISAs for the support of their PK studies and upcoming clinical trial.
  • Spherosense, Inc
    R&D Consultant
    Spherosense, Inc Nov 2008 - Sep 2009
    • Support biomarker assay development and validation, application of bioassays to clinical trials, assay validation and transfer technology issues for bioassays in a new a novel platform. • Assist in establishing a GMP and SOP document system.
  • T2 Biosystems
    Director Of Assay Development
    T2 Biosystems Dec 2007 - Nov 2008
    Leading the development of GMP clinical diagnostics assays on a new, novel instrument platform.
  • Cs-Keys, Inc., Indianapolis, In
    R&D Consultant, Acting Vp Of R&D.
    Cs-Keys, Inc., Indianapolis, In Jun 2007 - Sep 2008
    •Start up company specializing in cancer specific diagnostic marker. •Lead group of four scientists to bring an academic project to a developmental setting. Including all assay development, robustness and manufacturability of the product. •Established a GMP and SOP document system for the company.
  • Biovest , Inc.
    Associate Director Of Analytical Development
    Biovest , Inc. Aug 2006 - Jun 2007
    Responsibilities include establishing an Analytical development program at BioVest to support the BLA of the phase III Cancer vaccine. Since arriving at BioVest, I have implemented 8 new ELISA assays, IEF, Immunoblots and a SEC-HPLC methodology for analysis of the intermediates and drug products.
  • Gsk (Formally Shire Biologics)
    Associate Director Bioanalytical Development
    Gsk (Formally Shire Biologics) Mar 2003 - Jun 2006
    Brentford, Middlesex, Gb
    Responsibilities include overseeing the bioanalytical development and animal research groups (9 persons). Interfacing with research facility. Development of bioanalytical assays to support vaccine development. Coordinating product research and development efforts with the Canadian Research facility.
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  • Microbiotix, Inc
    Director Of R&D
    Microbiotix, Inc 2000 - 2003
    Us
    Microbiotix, Inc is a small start-up drug discovery company focused on anti-infectives. Responsible for managing the research program and overseeing research of 6 scientists (including 3 Ph.Ds) developing antibacterial and antiviral therapeutic products, including a drug discovery program for antibacterial agents, with one compound that has been identified as a lead candidate for drug development. Prepare and implement all protocols and documentation (SOPs) for R&D department, prepare written and oral material as requested by business development to support venture capital fund-raising, preparation and submission of scientific manuscripts and SBIR applications, inter-phase with other companies in order to see that joint projects are completed in a timely fashion.
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  • Bayer Diagnostics, Inc
    Manager Of Protein Chemistry
    Bayer Diagnostics, Inc 1997 - 2000
    Leverkusen, North Rhine-Westphalia, De
    Responsible for a group of 20 scientists (BS, MS, PhDs) involved in the Development of FDA approved clinical diagnostics automated assays for oncology and cardiac disease markets.
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  • T Cell Diagnostics, Inc
    Director Of R&D
    T Cell Diagnostics, Inc 1993 - 2000
    Responsible for a multi-departmental function, total personnel of ~20 scientists including R&D, Technical Support and Clinical Affairs/ Clinical Trials. The company’s specific goals were the development of diagnostics kits for autoimmune disease monitoring. Responsible for the development of new products as well of support of marketed products. Worked with marketing to set design goals and insure delivery of goals. Worked with manufacturing to insure timely product transfer. Identification of clinical utilities for newly identified markers. The potential of automation these assays was also part of the R&D function. Provided written and oral material to marketing of the products.
  • Behring Diagnostics, Inc. Denham, Ma
    Senior Scientist.
    Behring Diagnostics, Inc. Denham, Ma 1991 - 1992
    • Supervised a group of scientists in the development of three clinical assays for an automated instrument. These assays include: Ferritin, Myoglobin, Thrombin-anti-Thrombin. Interacted with marketing in setting design goals and insuring delivery of said goals them
  • Gene-Trak Systems, Inc. Framingham, Ma
    Project Leader
    Gene-Trak Systems, Inc. Framingham, Ma 1988 - 1991
    •Supervised 1 scientist. Responsible for the development and launch of DNA-probe based assays for the food diagnostic industry. Assays included; S. aureus and Salmonella. Additional work included technical support to manufacturing, quality control, marketing and sales. •Development and characterization of new DNA probes to enhance existing products.

Kim Foster Skills

Biotechnology Glp Assay Development Drug Discovery Gmp Fda Validation Elisa Lifesciences Clinical Development Life Sciences Vaccines Protein Chemistry Quality Assurance Laboratory Cell Culture Sop Analytical Chemistry Hplc Science Good Laboratory Practice

Kim Foster Education Details

  • Umass Chan Medical School
    Umass Chan Medical School
    Pharmacology
  • Virginia Commonwealth University School Of Medicine
    Virginia Commonwealth University School Of Medicine
    Biochemistry
  • Virginia Tech
    Virginia Tech
    Biochemistry

Frequently Asked Questions about Kim Foster

What company does Kim Foster work for?

Kim Foster works for Verity Group

What is Kim Foster's role at the current company?

Kim Foster's current role is Foster Scientific , Inc.

What is Kim Foster's email address?

Kim Foster's email address is kf****@****msn.com

What is Kim Foster's direct phone number?

Kim Foster's direct phone number is +150886*****

What schools did Kim Foster attend?

Kim Foster attended Umass Chan Medical School, Virginia Commonwealth University School Of Medicine, Virginia Tech.

What are some of Kim Foster's interests?

Kim Foster has interest in Collecting Antiques, Exercise, Home Improvement, Reading, Shooting, Gourmet Cooking, Sports, The Arts, Food, Home Decoration.

What skills is Kim Foster known for?

Kim Foster has skills like Biotechnology, Glp, Assay Development, Drug Discovery, Gmp, Fda, Validation, Elisa, Lifesciences, Clinical Development, Life Sciences, Vaccines.

Who are Kim Foster's colleagues?

Kim Foster's colleagues are Higor De Jesus, André Barsi, Gabriela Cândida N., Felipe Mattavelli, Anjaneya Bottolla, Jéssica Cavalcanti, Thiago De Moraes.

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