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Futran Solutions · 3 days ago
Validation Project Manager
Seattle, WA
Contract
Hybrid
Mid Level
2+ years exp
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Hiring Manager
Vijay kumar (L.I.O.N)
Insider Connection @Futran Solutions
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 software’s, 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
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
Experience in management of external contract testing
Bilingual Japanese/English is a plus
Company
Futran Solutions
Futran Solutions is a Digital Technology organization focused on Data Analytics, Cloud, Automation and New Age App Development.
201-500 employees
H1B Sponsorship
Futran Solutions 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 (1)
2022 (16)
2021 (18)
2020 (20)
Funding
Current Stage
Growth StageLeadership Team
Anil Vazirani
Chief Executive Officer
Jyoti Vazirani
Chief Executive Officer and Founder
Company data provided by crunchbase
