ImmunoGen was acquired by AbbVie

• Provide scientific subject matter expertise and oversight of suppliers performing GCP/GLP analytical testing across all clinical trial phases and non-clinical protocols• Assays range from PK, ADA, NAb, and TK through development, validation and production• Facilitate cross functional projects though organized and efficient communication of timelines, updates, reports and recommendations to management teams• Ensure clinical studies are conducted in compliance with study protocols, contracts, guidance documents, and applicable regulations• Perform data review and analysis to ensure data integrity and provide recommendations for corrective actions when necessary• Request, review, and submit scopes of work for purchase order and monitor funds throughout the duration of a study including approving invoices• Manage a team of direct reports consisting of four Project Coordinators and two Project Managers to ensure all study timelines are being met and goals are being obtained for further development

• Interact with Business Development Managers, Director of Client Services, Clients and potential Clients to create Proposals for bioanaltical studies, RFPs and RFIs for Immunochemistry and LCMS services• Read pre-clinical and clinical trial protocols in order to gather required information to compose Proposals while communicating questions to the client• Assist in negotiations and trouble shooting of difficult Client contracts and Client situations• Work closely with the Vice President of Pharmaceuticals when negotiating rate cards and setting fees for services• Ensure that all contracted revenue is captured in the WIP, CRM and Proposal Tracker• Provide a weekly Lead Indicator Report for all Business Development Managers consisting of all signed and unsigned Proposals to track current revenue and upcoming revenue• Attend expositions and meetings to work the Intertek booth to recruit and inform potential clients of the services Intertek provides• Maintain client relations and follow up with said clients on all open Proposals• Regularly communicate with clients via email, phone, and conference calls• Responsible for understanding and following GLP guidelines and laboratory SOPs

• Developed, optimized, and troubleshot analytical assays (ELISA, ECL), both independently and within a group for Quality Assurance review and release • Communicated with clients daily about the status of clinical and preclinical studies• Personal oversight of an average of 5 clients and 20 ongoing projects per quarter• Project Lead when meeting with and communicating with clients• Responsible for following GLP guidelines for validation and sample analysis of clinical and preclinical studies• Scheduled and prepared development and validation worksheets for analysts, reviewed final validation data, wrote final validation reports, and organized validation notebooks• Composed Bioanalytical Procedures and SOPs • Maintained detailed and accurate documentation of laboratory work, client samples, and reagents according to GLP and Intertek guidelines• Received, logged in, and assigned storage locations for sponsor and commercially available reagents • Monitored reagent inventory to ensure that all current timelines were met for development, validation, and sample analysis

• Performed quantitative, qualitative, and semi-qualitative assays by ELISA and ECL during assay development, validation, and sample analysis in accordance with GLP guidelines• Validated assays by evaluating the following parameters of each test method: linearity of dilution, drug tolerance, selectivity, sensitivity, and specificity• Conducted ELISA and ECL assays using cell culture techniques such as preparation of cells, cell splitting, and cell counting

• Performed quantitative ligand binding assays • Validated methods in a scientifically accurate fashion according to SOPs • Documented and performed all laboratory work in accordance with GLP regulations, in addition to client and ICON SOPs• Prepared buffers and solutions in accordance to client and in-house protocols• Performed calibration and routine maintenance of lab equipment including plate washers, plate readers, and precision liquid handling systems• Designed and implemented inventory system to improve and increase efficiency of the sample login group