QC Method Transfer and Validation Scientist (Sun-Wed)

SmartRecruiters, Inc.; Sanford (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and/or视

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Scientific seeks a QC Method Transfer and Validation Scientist to support method transfer and validation activities onsite in Sanford, NC. The role involves data analysis and generation of protocols/reports for analytical techniques with emphasis on GMP-compliant testing.

The candidate should have a BS in Chemistry or related field and at least 2 years of lab experience, plus experience with HPLC and Empower 3, and familiarity with USP/EU guidelines.

Qualifications

• BS in Chemistry or similar field with minimum 2 years in a lab.
• Experience with HPLC and Empower 3.
• GMP/cGMP environment experience.
• Familiarity with USP and EU guidelines.
• Strong communication and problem-solving skills.

Responsibilities

• Collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation.
• Data analysis, protocol/report generation, and troubleshooting analytical techniques such as HPLC, CE, and ELISA.
• The role requires strong technical expertise and attention to regulatory requirements in a GMP-compliant environment.

Skills

HPLC

Empower 3

Data analysis

Regulatory compliance

Education

Bachelor's degree in Chemistry or related field

Tools

HPLC

Empower 3

Job description

QC Method Transfer and Validation Scientist (Sun-Wed)

• Full-time

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.

This position is responsible for supporting analytical method transfer and validation activities to ensure robust and compliant testing of biologic products.

• Collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation
• Data analysis, protocol/report generation, and troubleshooting analytical techniques such as HPLC, CE, and ELISA
• The role requires strong technical expertise and attention to regulatory requirements in a GMP-compliant environment

This role is onsite in Sanford, NC. There are no public transportation options to the site.Ability to support outside standard hours may be needed.

• BS in Chemistry or similar field with a minimum of 2 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
• HPLC and Empower 3 experience
• Familiarity with USP, EU guidelines
• Effective oral and written communication
• Strong problem-solving skills
• 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

This position is Full-Time,Sunday to Wednesday 7 am - 7 pm. Candidates currently living within a commutable distance of Sanford, NCare 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.