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Technical Project Lead, MS&T - Process Engineering

Company: ThermoFisher
Location: Somerville
Posted on: May 3, 2021

Job Description:

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific InformationThe Technical Project Lead in the Manufacturing Science & Technology group will report into the Technical Project Lead Manager. This position is located in Cambridge, MA supporting the Viral Vector Service group.How will you make an impact?The Technical Project Lead is responsible to ensure that all technical aspects of a project are managed either directly or in collaboration with the Project team, ensuring that products/processes are compliant with company and regulatory quality standards. What will you do? Be the primary technical interface with clientsPerform technical review for internal and client project documents (tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports).Attend and/or lead internal and client project meetingsProvide leadership on technical strategy and execution from project initiation through scale up and tech transfer.Provide technical assessment on project change controls and deviationsPerform equivalency assessments/gap analyses during tech transfer activities and sourcing/designing materials or equipment as neededWork closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.How will you get here?EducationB.S - required. Ideally in life sciences, engineering, or equivalent technical field and 8years of experience - preferred.MS and 6years of relevant experience or a PhD and 4years of relevant experience - preferred.ExperienceDemonstrated manufacturing technical support experience in a Viral Vector, Biologics, or vaccine productionA sound understanding of viral vector production and analytics, scale-up principles, process validation, and regulatory strategies.Experience in research & development or manufacturing a plus.Knowledge, Skills, AbilitiesAbility to lead teams and manage othersProficient in Microsoft Office program suiteStrong documentation practices, organizational skills, and attention to detailStrong verbal and written communication skillsExcellent interpersonal skillsAbility to work collaboratively and independentlyStrong decision-making and problem solving skillsAbility to elicit cooperation from a wide variety of sources, including many departments within the company and work as a team playerAbility to effectively prioritize and execute tasks in a dynamic environmentExperience with Statistical and data analysis a plusFamiliarity with following software packages a plus: Visio, JMP, and MS ProjectFamiliarity with project management knowledge and skills a plusKnowledge of FDA, EMA, and other relevant regulatory environments is a plus.Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .JobSummaryJob number: 143886BRDate posted : 2021-03-23Profession: EngineeringEmployment type: Full-TimeSDL2017

Keywords: ThermoFisher, Somerville , Technical Project Lead, MS&T - Process Engineering, Other , Somerville, Massachusetts

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