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LNP Process Development Engineer

Cepheid

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Fargo, ND
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Job Description

As posted by the hiring company

Job Overview:

Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.

Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

The Engineer I, LNP Process Developments leads development of new technologies and optimization of existing processes around the Lipid Nanoparticle (LNP) platform. This position focuses specifically on LNP process development, and acts as the LNP operational lead for all technical transfer activities to research and GMP manufacturing. The candidate is expected to be motivated and capable of efficient prioritization, planning and scheduling multiple projects to effectively meet pre-determined deadlines. The candidate should have experience with manufacturing and scale-up in a regulated (ex. cGMP) environment.

Responsibilities

  • Lead all technical transfer activities of Research Grade and GMP LNP manufacturing and formulation
  • Engage in research and development of new LNP services and technologies in collaboration with other Danaher Operating Companies
  • Lead technical transfer and training of manufacturing staff through confirmation and/or engineering batches.
  • Act as subject matter expert (SME) to provide technical support and troubleshooting to business and operations teams
  • Create project summary reports and present findings and recommendations to internal or external customers
  • Assist in maintaining raw material and consumables inventory needed for LNP manufacture services
  • Plan inventory requisitions and capex requirements
  • Lead drafting of Standard Operating Procedures and production records or master batch records
  • Review technical transfer and process description documents in determining feasibility and scalability of incoming production unit operations
  • Work with the R&D team to research and assess process/technology improvements
  • Assist Metrology as needed to perform equipment calibration, preventative maintenance, and qualification/validation
  • Communicate the status of operations, process issues, and safety and maintenance issues to appropriate area management
  • Work with technical operations to ensure smooth transition for research grade projects into GMP manufacturing
  • Perform appropriate aseptic technique and gowning as required for a GMP environment
  • Help to resolve quality issues and CAPA’s by assisting with lab investigations, conducting root cause analysis, and developing implementation plans.
  • Complete Quality Metrics Tracking

Qualifications

  • 2+ years of process development, engineering, validation, and/or manufacturing experience required. Experience working as CDMO is a plus
  • Experience in RNA manufacturing, experimental design, and data analysis preferred
  • Experience working within a regulated cGMP environment
  • Basic knowledge in biologics downstream bioprocessing
  • BS degree in a scientific field is required.
  • MS degree preferred

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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