Job Description:

• 50% onsite
• work hours- M-F (need to be flexible to meet Japan timings)
• Bilingual Japanese/English is a plus
• bachelor's degree required
• Qualifications, skills and education requirements 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)