SSi People · 2 days ago

Project Manager

Seattle, WA

Full-time

Onsite

Mid Level

2+ years exp

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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

Qualification

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Analytical methodsAssay qualificationMethod validationRelease methodsCGMP regulationsFDA regulationsEMA regulationsICH guidelinesUSP guidelinesEP guidelinesTechnical writingQC lifecycle managementProject managementProblem-solvingHard-workingTime managementCommunicationInitiativeResourcefulnessFlexibilityTeamworkPrioritizationContract Testing Management

Required

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