Kate Patterson Email & Phone Number

Somerville, Ma, Us

Woburn, Massachusetts, United States

-Providing oversight and supervision of staff and resources performing bioanalytical studies including development, qualification, validation, and sample testing-Overseeing resource planning and allocation, Sponsor related communications, scientific and technical review, troubleshooting, and mentoring-Collaborating with Senior Management to meet financial goals of the organization-Responsible for project compliance with cGxP regulations-Working with management and QAU to improve quality systems-Serve as SME on any activities associated with ligand binding assays including but not limited to immunogenicity, pharmacokinetic, pharmacodynamic/biomarkers

-Function as Project Manager on client projects.-Function as Principal Investigator on GxP studies.-Coordinate client projects which include evaluating project needs, providing consultation, and supervising the project through completion.-Reserach new projects and create project plans.-Generate associated project documents including SOP's, validation protocols and reports, and sample analysis protocols and reports.-Providing leadership, mentoring, and training several scientists, senior research associates, and junior research associates. -Train new employees on sample analysis, assay validation, and assay development procedures and techniques.

-Serve as team leader and/or PI on R&D and GXP projects-Lead the technical and scientific aspects of development, qualification, and validation of new assays-Point of contact for the clients, study director, and other project staff-Write SOPs, validation protocols, validation reports, bioanalytical sample analysis reports, etc. -Sample analysis under RUO/GLP/ cGMP conditions-Provide high quality documentation of lab related related activities including assay batch record, sample inventory, etc. -Perform a QC function to review data and reports ensuring the accuracy of all lab-related processes-Oversee and manage lab equipment, maintenance, and calibration

-Sample analysis following established SOPs under RUO/GLP/cGMP conditions.-Write SOPs, Validation Protocols and Reports.-Lead the technical aspect of development and validation of new assays.-Ensuring the accuracy and timeliness of all laboratory-related processes.-Providing technical assistance to assigned research staff, train other Research Associates.-Providing high quality documentation of all lab related activities, including, for example, assay batch record, sample inventory, etc.-May serve as a team leader for R&D projects.-Maintaining regular communication with scientists, study director and other project staff as well as external clients.-Adhering to all laboratory standards as defined in each written SOP.

-General laboratory tasks including buffer preparation, sample logging and handing, shipping samples to or for clients, equipment maintenance, lab maintenance, and ordering supplies-Sample analysis following established SOPs-Performing GLP/cGMP assays-Assist in development and validation of new assays.-Providing technical assistance to assigned research staff-Ensuring the accuracy and timeliness of all laboratory-related processes-Adhering to all laboratory standards as defined in each written SOP