Be an early applicantLess than 25 applicantsPosted by Agency
TSR Consulting Services, Inc. · 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
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
Qualification
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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.
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)
Preferred
Bilingual Japanese/English is a plus
Company
TSR Consulting Services, Inc.
TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 50 years TSR, Inc.
501-1,000 employees
H1B Sponsorship
TSR Consulting Services, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
2022 (6)
2021 (1)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
unknown2012-08-20IPO· nasdaq:TSRI
Leadership Team
Thomas Salerno
CEO
Company data provided by crunchbase
