Project Manager

Seattle, Washington

Job Title: Project Manager

Location: Seattle, WA (50% onsite)

Job Summary:

  • The Project Manager will oversee method transfers and validations for the Cell Therapy Organization’s late-phase and commercial products. Reporting to the Global Quality group, this role involves managing lifecycle activities, coordinating cross-functional teams, and maintaining project timelines. The position requires flexibility for Japan time zones and benefits from bilingual Japanese/English skills.

Responsibilities:  

  • 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 an 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

 
Required Skills:  

  • 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

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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