Manage internal and external method transfer and method validation activities, including transfer protocol and reports generation, coordination of operators, identification of materials, critical reagents, and oversight of execution. Function as the analytical method transfer lead.

Responsible for developing and implementing several critical Quality programs to support QC and other functions within the company. Responsible for the development and implementation of assay maintenance and validation programs and technical oversight of contract laboratory methods, as well as project support on cross-functional teams.Develop, implement and manage analytical life cycle and maintenance programs including transfer, validation, assay trending and critical reagent monitoring. Support analytical method lifecycle efforts by developing validation protocols and writing final reports, conducting and/or leading qualification and/or validation experiments, and building comprehensive training plans.

•Act as lead analyst on multiple early and late phase biological projects including biosimilars -Developed, optimized, and qualified bioassays for transfer to the GMP testing environment -Responsible for the qualification of critical reagents, this includes procuring, expiry date evaluation, secondary vendor evaluation and writing protocols and reports -Trained and supervised personnel, contractors and across disciplinary department on performance of analytical methods, cell culture, and data analysis -Assisted QC in assay troubleshooting and evaluating assay performance •Led group in GLP systems implementation, provided guidance on GLP related issues to Bioassay group -Implemented assay trending program•Authored and reviewed GLP and GMP documentations including analytical methods, critical reagent: Certificate of Analysis, Standard Operating Procedures (SOPs), method qualification and development reports, and method transfer reports•Evaluated and implemented new technologies such as the use of ready to plate cells resulting in reduced overhead cost and increased efficiency•Review GLP and non-GLP release test and stability data to ensure data accuracy and adherence to documentation standards•Supported Process Development and Pharmaceutics formulation development by analyzing potency of product samples, review data and report results•Represented the Bioassay group for Process Team Meeting and Product Quality Team Meeting•Provided project management for contract laboratory testing for cross functional groups. -Coordinate project activities with internal and external groups -Coordinate and performed GLP testing for test article characterization•Co-author of the potency and biological properties sections of regulatory submissions (INDs)•Present data at project and group meetings to technical audience•Serve as subject matter expert for the implementation of Freezer Database for cell bank inventory management

•Analytical Method Transfer coordinator/manager for Amgen Washington Quality Control.-Managed, facilitated and drove the transfer and training of method from development group to QC Cellular Immuno Analytics for the characterization of biological activity of first in human clinical molecules.-Managed, facilitated the transfer and training of HPLC and ELISA’s assays from development group to QC.-Acted as technical experts on cross functional teams for assessment and documentation of the risks to successfully complete the project objective -Led transfer protocol and wrote transfer report. -Assisted in the IND filings.•Project lead for transferring new methods from AWA Global Cellular Analytical. -Represent AWA Cellular Immuno Analytics in PQT (Project Quality Team)-Trained analyst on transferred assays and test methods•Change control management for method revision, non-reg assessor for multiple change controls.•Provided project management for contract laboratory testing for cross functional groups.•Performed cell based, potency assays for release and stability of clinical molecules.•Maintained relevant cell lines for bioassays; including adherent, semi-adherent and non-adherent cell lines.•Managed inventory for critical reagents and provided oversight to junior staff as technical expert on molecule specific analytical methods. Generated protocols and qualification assays in a technical report.•Team member of the Maximo Operations Group:-Ensured consistency and policy for laboratory equipment across functional groups. -Coordinated with Facilities Engineer to ensure GMP critical equipment was within calibration and in appropriate working condition.

• Method Transfer coordinator/manager for Bioassay (International) -Coordinated, trained, transfer of cellular bioassay to Germany • Build inter-department relationships to ensure smooth product release• Project Management for outside contractors for cross functional groups.• Performed internal and external quality audits of contract vendors in collaboration with Quality Control Compliance as Quality Control representative.• Managed scheduling for the lab to ensure testing is completed within window.• Performed Bioassay and DNA contamination assay. Performed plasmid preparation and restriction mapping.• Performed Qualification and validation of equipment required for product testing.• Performed method validations. Created and revised SOPs as needed. Reviewed and approved data.• Supervised and trained staff members, included the manager as backup tester.• Managed complexities caused by Immunex to Berlex transition: -Independently carried entire workload of the lab as needed, including testing, support duties, instrumentation, reagent qualification, and sample handling.

• Transferred new method into lab, including development of assay, method validation, creation of SOP, troubleshoot assay related problems, and trained staff• Supported the move of Immunex staff members to temporary laboratory (Queen Anne) during the acquisition, while testing proceeded with no disruption. • Performed all IQ/OQ/PQ on equipments that were use for GMP testing, turning a GLP lab (Queen Anne) to a GMP lab.• Supported the set-up of Nexus lab by ensuring availability of equipment and supplies.• Supervised and trained staff members on all test methods and lab systems.• Maintained and scheduled samples for testing to ensure testing is completed within testing window.• Build inter-department relationships to ensure smooth product release.• Analyzed performance of controls for each test method.• Performed Bioassay, Receptor Binding, and Molecular Biology Assays according to SOPs. • Maintained adherent and non adherent cell lines.• Maintained critical reagents, chemical inventory, and lab supplies.• Wrote templates and protocols for assay validation.