GMP Laboratory Analyst

Eurofins PSS Insourcing Solutions; New London (CT); On-site; USD 52,000 - 78,000; Full time

Job summary

Eurofins USA PSS Insourcing Solutions in Groton, CT is seeking a detail-oriented analytical associate to support microbiological testing and GMP operations. The role involves performing TVC, appearance, coliform and other microbial tests in a GLP/GMP environment and maintaining rigorous documentation.

You will work with HPLC, Raman and FTIR, and utilize eLN and LIMS systems for data trending and release testing, collaborating with a team to ensure quality and compliance across development stages.

Qualifications

• Bachelor’s degree in science or related field or equivalent experience.
• Strong computer, scientific, and organizational skills.
• Experience with eLN, LIMS, and data trending.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self-motivated, adaptable, and positive.
• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with policies.

Responsibilities

• Support analytical & microbiological testing and lab operations in a GMP environment.
• Perform TVC, appearance, Coliform and Choline microbial testing and GMP analytical testing.
• Maintain documentation and safety practices in GLP/GMP settings.
• Utilize analytical methodologies and systems to support GMP release and stability testing of clinical supplies.
• Analytical testing includes compendial testing, disintegration, dissolution, HPLC/UPLC, and related methods.
• Set up and analyze drug substance and drug product stability samples.
• Method development and validation of analytical methods for drug substances and products.

Skills

Computer skills

Scientific knowledge

Organizational skills

eLN & LIMS

Data trending

Communication

Teamwork

Self-motivation

Education

Bachelor’s degree in science

Tools

HPLC

Raman

FTIR

eLN

LIMS

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

We’re seeking a detail-oriented and motivated individual to support analytical & microbiological testing, and lab operations in a GMP environment. This role involves performing TVC, Appearance, Coliform and Choline microbial testing and GMP analytical testing. The ideal candidate has hands‑on analytical and microbiology experience, strong documentation skills, and thrives in a fast-paced, team-oriented setting.

• Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
• Experience with GMP, microbiological testing, wet chemistry, HPLC, Raman, FTIR
• Responsible for water testing in support of manufacturing facilities including total viable counts (including filtration and pour plate), appearance, coliform and chlorine testing.
• Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post-packaging support.
• Analytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV), and compound-specific methods.
• Set up and analysis of drug substance and drug product stability samples.
• Method developmentand validation of analytical methods for drug substance and drug product

Qualifications

• Bachelor’s degree in science or other related degree concentration, or equivalent directly related experience.
• Strong computer, scientific, and organizational skills.
• Experience with eLN, LIMS, and data trending.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Preferred Qualifications

• Experience in a GMP laboratory, microbiology and analytical chemistry preferred.
• Experience with eLN, LIMS, and data trending.

Additional Information

• Position is Monday-Friday, 8-5. Overtime as needed
• May be requested to work on weekends, overtime, and holidays based on business needs
• Candidates currently living within a commutable distance of Groton, CT 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
• Authorization to work in the United States indefinitely without restriction or sponsorship

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