QC Method Transfer and Validation Scientist (Sun-Wed)

Eurofins PSS Insourcing Solutions; Sanford (NC); In loco; USD 65.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Descrizione del lavoro

Eurofins USA PSS Insourcing Solutions in Sanford, NC is seeking a Biochemical Analyst to support analytical method transfer and validation for biologic products in a GMP setting. You will collaborate with internal and external partners, analyze data, and prepare reports while ensuring regulatory compliance.

The role requires 2+ years in a lab, experience with HPLC/ELISA and Empower 3, and familiarity with USP/EU guidelines.

Competenze

• 2+ years of laboratory experience in a GMP environment.
• Experience with analytical techniques such as HPLC, CE, ELISA, and PCR.
• Familiarity with USP and EU guidelines.
• Strong verbal and written communication and ability to work independently or in a team.

Mansioni

• Support method qualification, validation protocols, and transfer documentation.
• Analyze data, generate protocols/reports, troubleshoot analytical techniques.
• Collaborate with internal and external partners to ensure compliant testing in a GMP setting.

Conoscenze

Laboratory experience

Regulatory compliance

Communication

Independence

Formazione

BS in Chemistry

Strumenti

HPLC

Empower 3

PCR

Descrizione del lavoro

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.

• 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, PCR
• 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.

Qualifications

• BS in Chemistry or similar field with a minimum of 2 years of experience working in a laboratory environment.
• Strong pipetting experience is required
• 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
• 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

Additional Information

This position is Full-Time, Sunday to Wednesday 7 am - 7 pm. 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.