Kim Foster Email & Phone Number

Boylston, MA, US

Perform three site audits Voyager for CRO facilities April, May 2023 and January 2024

• CMO method SOP and method qualification review
• Batch Record Review and Reports, SOP, etc. review for the CMO Site

• 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.

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.

Assist in the writing and editing development reports

Provide technical review, and support for CMC

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.

Newton, MA, US

• Draft/Author Technical Documents related R&D activities
• Draft /Author SOPs and work instructions for lab equipment and test methods.

• 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.

• QA GLP Consultant/ Auditor (as requested)
• Perform site audits of GCP/GMP/GCP facilities, as requested.
• Assist sites to set up GLP documentation systems.

• 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

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

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.
• 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.

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.

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.

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

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.

• 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

GLP auditor for the Bioanalytical division for the Quality assurance department.

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.

• Support bioanalytical test method development and validation, to support clinical trials.

Assist bio analytical group in the validation of their ELISAs for the support of their PK studies and upcoming clinical trial.

• 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.

Leading the development of GMP clinical diagnostics assays on a new, novel instrument platform.

• 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.

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.

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.

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.

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.

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.

• 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.

• 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.
• Development and characterization of new DNA probes to enhance existing products.

Postdoc, Pharmacology

Phd, Biochemistry

Bs, Biochemistry