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Sunrise Systems, Inc. ยท 2 days ago
Project Manager
Seattle, WA
Full-time
Onsite
Entry, Mid Level
$65/hr - $68/hr
2+ years exp
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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 timelines, monitor progress, identify risks, and establish mitigation plans
Coordinate internal cross-functional team members on project deliverables
Develop and implement proactive initiatives towards efficiency
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
Experience with implementing release methods in a commercial QC facility.
Experience in management of external contract testing is preferred.
Benefits
ACA-compliant medical coverage
Dental insurance
Vision insurance
Sick time benefits
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1,000 employees
H1B Sponsorship
Sunrise Systems, 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
2022 (13)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase
