27 applicantsPosted by Agency
Integrated Resources, Inc ( IRI ) ยท 3 days ago
Project Manager
Seattle, WA
Contract
Hybrid
Mid Level
2+ years exp
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Hiring Manager
Ashi Khandelwal
Insider Connection @Integrated Resources, Inc ( IRI )
Responsibilities
Manage commercial and late phase DP method lifecycle activities across a multi-product portfolio
Operational management lead for the implementation of method lifecycle and method maintenance programs
End to end management for method transfer & validation activities at contract test sites and internally
Create project plans, develop and update timelines, monitor progress, identify risks, establish mitigation plans, lead meetings, and document outcomes
Coordinate internal cross-functional team members on project deliverables
Develop and implement proactive initiatives towards efficiency
Support related change controls
Liaise with internal and external technical experts
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
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)
Preferred
Bilingual Japanese/English is a plus
Company
Integrated Resources, Inc ( IRI )
Integrated Resources Inc.
501-1,000 employees
H1B Sponsorship
Integrated Resources, Inc ( IRI ) 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 (10)
2022 (11)
2021 (17)
2020 (39)
Funding
Current Stage
Late StageRecent News
Hiring | Recruitment | Placement | Executive Job Search | Job Posting's | Talent Acquisition
2022-03-01
Company data provided by crunchbase
