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Advent Global Solutions · 2 days ago
Validation - Project Manager
Summit, NJ
Contract
Onsite
Entry, Mid Level
2+ years exp
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Responsibilities
Manage commercial and late phase DP method lifecycle activities across a multi-product portfolio.
Lead operational management for the implementation of method lifecycle and method maintenance programs to support cell therapy methods.
Manage end to end 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.
Communicate progress to direct reports and cross-functional teams using visual and analytical tools.
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.
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)
Preferred
Experience in management of external contract testing is preferred.
Fluent management for PM tools such as Smartsheet, Microsoft Time Pro, Microsoft Project Plan or others.
Experience with project status communication (visual, verbal, writing)
Company
Advent Global Solutions
An IT services company.
1,001-5,000 employees
H1B Sponsorship
Advent Global 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 (24)
2022 (27)
2021 (54)
2020 (57)
Funding
Current Stage
Late StageLeadership Team
Raj Chappidi
Founder, President, and CEO
Recent News
Company data provided by crunchbase
