Biologic QC Method Transfer & Validation Scientist

Eurofins PSS Insourcing Solutions; Sanford (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions in Sanford, NC is seeking an analytical chemist to support method transfer and validation for biologic products in a GMP setting. The role requires strong technical expertise and adherence to regulatory requirements.

Responsibilities include collaborating on qualification/validation protocols, data analysis, and generating protocols/reports; experience with HPLC, CE, and ELISA is needed. On-site with potential weekend support; commutable to Sanford, NC.

Qualifications

• BS in Chemistry or similar field with at least 4 years of laboratory experience.
• Experience working with proteins or carbohydrates.
• Experience in a Good Manufacturing Practices (cGMP) environment.
• Experience with analytical standards, reagents, and laboratory instruments.
• Strong pipetting skills.
• HPLC and Empower 3 experience.
• Familiarity with USP and EU guidelines.
• Excellent oral and written communication skills.
• Strong problem-solving skills.
• Flexible to support outside standard hours and potential weekend shifts.
• Must be organized, self-motivated, and able to work independently or in a team.
• Authorization to work in the United States indefinitely without sponsorship.

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.

Skills

Strong problem-solving skills

Effective oral and written comms

Strong computer skills

Education

BS in Chemistry or similar field

Tools

HPLC

Empower 3

Job description

Eurofins USA PSS Insourcing Solutions in Sanford, NC is seeking an analytical chemist to support method transfer and validation for biologic products in a GMP setting. The role requires strong technical expertise and adherence to regulatory requirements.

Responsibilities include collaborating on qualification/validation protocols, data analysis, and generating protocols/reports; experience with HPLC, CE, and ELISA is needed. On-site with potential weekend support; commutable to Sanford, NC.