Scientist I - Analytical Method Validation

At Aldevron we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated forwardthinking associates share this goal by combining bestinclass products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together we accelerate the discovery development and delivery of solutions that safeguard and improve human health.

This position is part of the Quality and Regulatory Affairs Department located in Fargo North Dakota and will be onsite. At Aldevron we combine bestinclass products and servicewith the ideal operating environment to lay the groundworkfor vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method Validation team in matters related to analytical test method validation and test method transfer. Additionally you will support test method continuous improvement initiatives as part of the analytical procedure life cycle. In this position you will work collaboratively with crossfunctional internal teams as well as clients to ensure test methods utilized at Aldevron are qualified/validated in accordance with current regulatory expectations in a phaseappropriate manner.

This role is onsite in our Fargo ND location.

In this role you will have the opportunity to:

• Support test method validation activities including method transfers and clientspecific method validation with minimal assistance.
• Collaborate with Analytical Method Development and Quality Control (QC) Laboratory Associates to support the implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids proteins and lipid nanoparticles (LNPs).
• Support deviation investigations (e.g. Out of Specification (OOS) Quality Events) by providing technical assistance and contributing to Root Cause identification and Corrective Actions and Preventative Actions (CAPA).
• Develop and execute data collection plans interpret data draft protocols and study reports engage in customer interactions in support of test method validation activities.
• Act as a technical SME and assist in developing and training Analytical Method Validation Associates in more complex analytical technologies.

The essential requirements of the job include:

• Basic understanding of test method validation test method transfer and method development.
• Foundational knowledge of FDA EU and ICH regulations related to test method validation and transfer.
• Experience with validation of test methods for nucleic acids (mRNA DNA) and/or protein products.
• Familiarity with analytical techniques commonly used for nucleic acids and proteins (e.g. HPLC ELISA capillary electrophoresis (PA800/BioPhase8800 q/dPCR).
• BS degree and 2 5 years of experience MS degree with 1 years of experience or PhD with 0 years of relevant experience.

It would be a plus if you also possess previous experience in:

• Experience in technical writing and supporting investigations in a cGMP compliant Quality Control Laboratory setting.
• Experience working with external testing laboratories and CMO development and manufacturing partners.
• Familiarity with lipid nanoparticles (LNPs) and associated analytical test methods.

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Join our winning team today. Together well accelerate the reallife impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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