Brittany Gaines Email & Phone Number

Bedford, Massachusetts, US

• Develops and maintains CMO Quality programs and processes designed to improve CMO performance, productivity, and process validation.
• Leads the integration of clinical-stage radiopharmaceuticals into the organization
• Leads investigations and assures follow-up and corrective action closure to reduce and eliminate CMO-related defects.
• Actively supports management and resolution of key issues which impact product release at CMOs.
• Actively involved in providing Quality support and technical direction for New Product Development, as part of technology transfer teams, from Research and Development to Manufacturing though scale-up process/product.
• Conducts on-site audits of CMOs in the US, EU, and UK.

Philadelphia, Pennsylvania, US

• Major accomplishments:
• Authored submissions and worked closely with regulatory authorities to obtain FDA and Health Canada Emergency Use/Interim Order Authorizations for SARS-CoV-2 products (sample prep consumables, thermocyclers, mobile.
• Recruited, interviewed, selected, onboarded, trained, developed, coached, and supported a growing team comprised of Quality Control, Quality Assurance, and Quality Engineering from a group of 1 to a group of 16+, with.
• Instrumental in the scale-up from one manufacturing shift (four operators) to four shifts (100+ operators) and duplicate manufacturing lines totaling a 7500% increase in consumables manufacturing and a 377% increase in.
• Developed, implemented, executed, improved, and maintained Quality System, QMS training schedule, on-boarding, and new employee training
• Developed, implemented, executed, improved, and maintained documentation for the manufacture and testing of a novel molecular diagnostics platform as well as >80 biological sample preparation productsMain.

Philadelphia, PA, US

• Led successful and timely technology transfer projects for multiple pharmaceutical products in several countries
• Led comprehensive investigations into defects and failures in the field by troubleshooting and identifying critical issues with processes and leading the way towards making improvements
• Performed audits of US and European manufacturing sites for adherence to established processes and documentation, maintenance of equipment and facilities, GMP / GDP requirements, deviation / OOS / CAPA implementation.
• Established and maintained productive and cooperative relationships with vendors, contract manufacturing sites, and internal groups
• Troubleshooting of Quality Control test method and production issues with contract manufacturing sites
• Conducted site visits to contract manufacturing sites to troubleshoot issues and/or to observe production and testing of Avid products and review for compliance with Avid approved procedures and PET GMP regulations

Philadelphia, PA, US

• Developed process for knowledge transfer to contract manufacturing sites
• Assisted with managing multiple complex technology transfer projects related to the manufacturing and testing of current and new radiopharmaceuticals
• Communicated with contract manufacturing sites, vendors, and internal groups regarding technical and compliance issues, timelines, and data
• Trained staff at contract manufacturing sites on manufacturing and testing methods
• Ensured proper GMP controls for manufacture and release of radiopharmaceuticals
• Initiated process to validate and complete documentation required for introduction of new equipment

Saint Genis Pouilly, FR

• Responsible for the organization and management of multiple technology transfer projects to various sites within Italy, France, and Spain, and ensuring continued success
• Responsible for liaising with three third-party companies for the transfer of technology of clinical-stage radiopharmaceuticals to various sites in Europe including QC implementation and validation, product validation.
• Researched and worked on optimizing the synthesis of [18F] fluoroestradiol and nucleophilic [18F] fluoro-l-dopa
• Routine synthesis and quality control of F-18 radiotracers, including fluoromethylcholine, fluorothymidine, fluorodeoxyglucose, sodium fluoride, fluoro-L-dopa, and for [Lu-177] LuDOTATATE
• Responsible for the periodic revalidation of quality control instrumentation including HPLC (UV/Vis, conductimetric, ionic, and gamma detection), GC, TLC

Saint Genis Pouilly, FR

• Research performed on [18F] fluorothymidine, [18F] Fallypride, [18F] FMISO
• Synthesis of [18F] fluoromethylcholine, [18F] fluorothymidine, [18F] Fallypride
• Responsible for the transfer of technology of [18F] fluoro-L-dopa in two sites (France and Italy) including the implementation of safety systems, installation of transfer lines, installation and testing of the.
• Wrote official procedures for the preparation, production, quality control, and performed training of new employees

New Haven, CT, US

• Synthesis and quality control of radioactive pharmaceuticals for clinic and research; O-15 water, F-18 fluorodeoxyglucose (FDG), N-13 ammonia, and various novel C-11 compounds
• Daily quality control operations included: HPLC analysis including determination of chemical and radiochemical purity, half-life, pH, sterility, apyrogenicity
• Other important functions included: cyclotron operation and maintenance, laboratory set-up and organization, creation and maintenance of chemical inventory, research schedule coordination, research and purchasing of.