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 development, product and process validation.• Conducts on-site audits of CMOs in the US, EU, and UK. • Reviews/executes Quality Agreements with CMOs and pharma partners.• Leads back room for pharma partner audits of Lantheus' QMS and CMO oversight activities.• Leads risk management activities to identify design and process risks and ensure mitigation in compliance with corporate procedures.• Leads teams/projects related to CMO complaint investigation, corrective actions and quality system excellence. • Builds, leads, and develops a team of professionals to support quality initiatives to support CMO production.

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 app, and lyophilized assays)• 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 1-7 direct reports at a time• 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 hardware manufacturing over 12 months• 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 responsibilities:Implementation and review of QMS; management review and executive team collaboration; author, update, and manage Standard Operating Procedure library in eQMS; risk/hazard analysis and mitigation; product complaint tracking and communication workflow; non-conforming materials/Material Review Board; implementation and management of critical equipment calibration and Preventive Maintenance schedule; evaluation of all non-conformances and assessment of quality impact, NCR/CAPA creation/management/closure; vendor qualification; manufacturing investigations; QC support; deviation management; change control; management and monitoring of receiving inspection documentation; creation and management of Certificate of Analysis and Safety Data Sheet libraries.

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 and closure• 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• Trained contract manufacturing site staff to correct deficiencies• Assisted with roll out of revised major quality testing procedures or production processes to contract manufacturing sites • Assigned and tracked root causes for production failures, and support programs / solutions to improve site production performance• Evaluation of OOS / deviation / CAPA investigation reports• Provided input for all changes to technical documents and for process improvement discussions with the CMOs• Authored technical documents including but not limited to testing protocols, technical reports, and SOPs • Reviewed completed manufacturing batch documentation

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• Reviewed qualification documents and batch records and identify errors • Identified suppliers and raw materials requirements associated with process transfer • Completed documentation and verification associated with technology transfer process• Identified and implemented process changes to enhance compliance and improve manufacturing process as required• Collaborated to develop timelines and resolution to issues• Wrote and reviewed technical documents including standard operating procedures, testing protocols, technical reports, batch files and technical transfer documents• Assisted in writing US and ROW contract manufacturing regulatory documents

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 and stability, documentation, and preparation for inspection by the competent authorities• 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 synthesis module and target materials, with more than 25 official documents written, including detailed training documents• 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 medical and chemical supplies and equipment, minimization of purchasing costs, training of new staff, creation and revision of SOPs