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LanceSoft, Inc. ยท 2 days ago
Validation - Project Manager
Seattle, WA
Full-time
Onsite
Mid Level
$55/hr - $65/hr
2+ years exp
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Responsibilities
Manage commercial and late phase DP method lifecycle activities across a multi-product portfolio
Lead the implementation of method lifecycle and method maintenance programs for cell therapy methods
Oversee method transfer & validation activities at contract test sites and internally
Create project plans, develop timelines, monitor progress, identify risks, and lead meetings
Communicate progress to direct reports and cross-functional teams using visual and analytical tools
Coordinate internal cross-functional team members on project deliverables
Develop proactive initiatives towards efficiency and support related change controls
Liaise with internal and external technical experts, represent the department on cross-functional drug product teams
Function as the Quality liaison with contract test labs during QC investigations
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
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)
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
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
1,001-5,000 employees
H1B Sponsorship
LanceSoft, 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 (20)
2022 (22)
2021 (46)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase
