50% onsite work hours- M-F (need to be flexible to meet Japan timings) Bilingual Japanese/English is a plus
Position Summary: Reporting to the Global Quality group, Analytical Sciences and Technology function, this position is accountable for the end to end management for method transfers & validations for the Cell Therapy Organization for late-phase and commercial products. This position also manages post-transfer life cycle activities to support Cell Therapy Drug Product Programs. Other accountabilities might be included for the same role based on the project assignation and team needs.
Manage commercial and late phase DP method lifecycle activities across a multi-product portfolio (methods for release and in-process controls in scope) Operational management lead for the implementation of method lifecycle and method maintenance programs to support cell therapy methods (drug product or as applicable). End to end management for method transfer & validation activities at contract test sites and internally.
Create project plans using PM softwares, develop, and update timelines, monitor and document progress, identify risks to project deliverables, establish and coordinate mitigation plans, lead meetings and document outcomes (meeting minutes). Using visual and analytical tools to communicate progress to direct report and to cross-functional teams and lead governances. Creates meeting minutes, project trackers, action & risk logs, Bill of Materials, master tables and all necessary tools to proactively and efficiently leading the project towards success. Coordinate internal cross-functional team members on project deliverables to maintain overall project timelines Develop and implement proactive initiatives towards efficiency Support related change controls. Liaise with internal and external technical experts This role may involve E2E management for DP release/in process establishment including coordination for planning and execution of bridging or Justification for specifications supporting cross-functional functions (as project R&R require). Function as the Quality liaison with contract test labs during QC investigations Represent the Cell therapy Analytical Sciences and Technology department on cross-functional drug product teams.
BS/MS in relevant scientific discipline and 2+ years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization. Experience in management of external contract testing is preferred. Knowledge of analytical method lifecycle, including assay qualification, transfer, validation and maintenance. Experience with implementing release methods in a commercial QC facility. Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, vaccines and/or biological products. Strong technical writing experience (general QC lifecycle management procedures) is required. Excellent verbal and written communication skills. Must possess effective time management and cross-functional communication skills, demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team. Ability to work effectively at a fast pace and with tight timelines. Comfortable with changing priorities and managing multiple projects. Ability to prioritize work independently Ability to influence, facilitate alignment and communicate as appropriate. Ability to identify risks and proactively develop mitigation plans Comfortable working in a multi-cultural environment Project Management experience (min 2 years) (PMP certificate or proven experience) Fluent management for PM tools such as Smartsheet, Microsoft Time Pro, Microsoft Project Plan or others. Experience with project status communication (visual, verbal, writing)
Validation - Project Manager • Seattle, WA, United States
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