QC Method Transfer and Validation Scientist

About the role

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.

Responsibilities

• 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.
• Support the site on-site in Sanford, NC, with flexibility to support outside standard hours and weekends.

Requirements

• 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 (GMP) 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.

Qualifications

• Authorization to work in the United States indefinitely without restrictions or sponsorship.

Preferred Experience

• Pathogen safety experience.
• Background with regulatory landscape.

Benefits

Position is full-time, Mon-Fri 8am-5pm. Flexibility to support outside standard hours and weekends is needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options; Life and disability insurance; 401(k) with company match; Paid vacation and holidays.

Pay

Not specified

Schedule

Mon-Fri 8am-5pm with flexibility to support outside standard hours and weekends.