Sr 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 and will be responsible for representing the Analytical Method Validation team as a subject matter expert (SME) on analytical test method validation test method transfer and will lead test method continuous improvement initiatives as part of the analytical procedure life cycle. In addition 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 the appropriate current regulatory expectations in a phaseappropriate manner.

Aldevron is seeking a highly skilled and experienced Senior Scientist to join our Analytical Method Validation team. In this role you will have the opportunity to:

• Serve as a Subject Matter Expert (SME):Collaborate with internal and external stakeholders on test method validation including method transfers clientspecific validation activities and process validation. Represent the Analytical Method Validation team in client and internal meetings.
• Evaluate New Testing Applications:Act as the Analytical Method Validation representative in the assessment of new testing applications and instrumentation. Work closely with Analytical Method Development and Quality Control (QC) Laboratory Associates to ensure successful implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids proteins and lipid nanoparticles (LNPs).
• Lead Deviation Investigations:Provide technical expertise as an analytical SME in deviation investigations (e.g. Out of Specification (OOS) Quality Events). Assist in identifying root causes and developing Corrective Actions and Preventative Actions (CAPA).
• Drive Continuous Improvement:Collaborate with department leadership to identify gaps and propose solutionbased approaches for continuous improvement ensuring the Analytical Method Validation team meets the companys priority projects.
• Develop and Train Associates:Mentor and train Analytical Method Validation Associates in test method validation principles and strategies including phaseappropriate validation approaches.

Essential Requirements:

• Expertise in Test Method Validation:Proven competency in test method validation transfer and development demonstrated through publications or previous experience.
• Regulatory Knowledge:Strong understanding of FDA EU and ICH regulations related to test method validation transfer and development.
• Experience with Nucleic Acids and Proteins:Handson experience in validating test methods for nucleic acids (mRNA DNA) and/or protein products.
• Analytical Techniques:Proficiency in analytical techniques such as HPLC ELISA capillary electrophoresis and PCR.
• Educational Background:PhD with 5 years of experience MS degree with 7 years of experience or BS degree with 10 years of experience.

Preferred Qualifications:

• Technical Writing and Investigation Leadership:Experience in technical writing and leading investigations in a cGMPcompliant QC Laboratory setting.
• Collaboration with External Partners:Experience working with external testing laboratories and CMO partners including support for process and cleaning validation.
• Lipid Nanoparticles (LNPs):Familiarity with LNPs and related analytical test methods for LNP drug product release.

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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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