Scientific Project Manager

The Scientific Project Manager supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity.

Please note:

this is a fully remote role, best suited for candidates located in the Pacific Time Zone or able to work Pacific Time hours, and will require travel at least twice per year to the client site, as well as occasional travel to vendor laboratories as needed. Essential Duties and Responsibilities Study Monitoring Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity. The initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management. Provide technical support to troubleshoot specific issues that impact the project. Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations Tech Transfer Implements transfer strategy and coordinates between the product team and technical experts. Responsible for establishing production phase monitoring requirements (PT and trending) Technical monitoring of assay performance and evaluation of transfer pass/fail criteria. Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity Ensures vendor adherence to project plan. Supplier Management Lead operational point of contact between vendor and client Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement. Department Support Assist with writing SOPs for new laboratories Assist with developing and implementing training documents and plans. Assist with process improvement initiatives Education and Experience B.S. in Life Sciences or related field. Minimum of 5 years of industry-relevant project, laboratory, and management experience. Demonstrated experience supporting immunogenicity programs, including anti-drug antibody (ADA) assessments, in a regulated bioanalytical or clinical development environment. Proven ability to perform data trending, analysis, and visualization using R (RStudio), JMP, and Minitab.