QC Method Transfer and 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 Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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.

Qualifications

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

Additional Information

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

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.