Scientist I - Analytical Method Validation

Aldevron LLC; Chaska (MN); On-site; USD 65,000 - 80,000; Full time

Job summary

A leading company in life sciences is seeking an individual for an Analytical Method Validation role in their Fargo location. The successful candidate will support test method validations and engage with various cross-functional teams while adhering to regulatory standards. This position requires a strong educational background and relevant experience in method validation, ideally in a cGMP QC environment.

Qualifications

• Basic understanding of test method validation and transfer.
• Knowledge of FDA, EU, and ICH regulations for validation.
• Experience in a cGMP QC lab is preferred.

Responsibilities

• Support test method validation activities and client-specific validations.
• Collaborate with internal teams for GMP testing.
• Assist in deviation investigations and technical training.

Skills

Understanding of test method validation

Knowledge of FDA regulations

Experience with validation of nucleic acids

Education

BS in relevant field, 2-5 years experience

MS with 1+ years relevant experience

PhD with relevant experience

Tools

HPLC

ELISA

Capillary electrophoresis

q/dPCR

Job description

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class 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 you 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 on-site. You will be a part of the Analytical Method Validation Team, reporting to the Sr. Manager of Analytical Method Validation. Your responsibilities include representing the team in analytical test method validation and transfer, supporting continuous improvement initiatives, and collaborating with internal teams and clients to ensure validation in line with regulatory standards.

Key Responsibilities:

1. Support test method validation activities, including transfers and client-specific validations.
2. Collaborate with Analytical Method Development and QC Laboratory Associates for GMP testing of nucleic acids, proteins, and lipid nanoparticles.
3. Assist in deviation investigations, root cause analysis, and CAPA processes.
4. Develop data collection plans, interpret data, draft protocols and reports, and engage in customer interactions.
5. Serve as a technical SME and assist in training associates in complex analytical technologies.

Minimum Requirements:

1. Basic understanding of test method validation, transfer, and development.
2. Knowledge of FDA, EU, and ICH regulations related to validation.
3. Experience with validation of nucleic acids and/or protein test methods.
4. Familiarity with analytical techniques such as HPLC, ELISA, capillary electrophoresis, q/dPCR.
5. Educational qualifications: BS with 2-5 years, MS with 1+ years, or PhD with relevant experience.

Preferred Experience:

1. Technical writing and investigative experience in a cGMP QC lab.
2. Experience with external labs and CMO partners.
3. Knowledge of lipid nanoparticles and related testing methods.

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Join us to accelerate the impact of science and technology. For more information, visit www.danaher.com.

Danaher is committed to equal opportunity employment and values diversity in our workforce. Accommodations are available for applicants with disabilities; contact [e-mail].