QC Method Transfer and Validation Scientist

Job description

This position is responsible for supporting analytical method transfer and validation activities to ensure robust and compliant testing of biologic products. The role requires strong technical expertise and attention to regulatory requirements in a GMP-compliant environment. Collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation. Perform data analysis, protocol/report generation, and troubleshooting analytical techniques such as HPLC, CE, and ELISA. This role is on-site in Sanford, NC. Flexibility to support outside standard hours and weekends is needed. The site is not accessible by public transportation options. Required Qualifications: BS in Chemistry or similar field with a minimum of 4 years of experience working in a laboratory environment Experience working with proteins or carbohydrates Experience working in a Good Manufacturing Practices {also cGMP} environment Experience working with analytical standards, reagents, and laboratory instruments Strong pipetting skills HPLC and Empower 3 Experience Familiarity with USP, EU guidelines Effective oral and written communication Strong problem-solving skills Flexible to support outside standard hours and potential for weekend support Excellent oral and written communication skills as well as strong computer skills Must be organized, self-motivated, and capable of working independently or in a collaborative environment Authorization to work in the United States indefinitely without restrictions or sponsorship Preferred Experience: Pathogen safety experience Background with regulatory landscape