Process Analytical Technology Associate

Eurofins USA PSS Insourcing Solutions • Groton, CT

1d • Onsite

About The Position

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. Role Responsibilities: Utilize PAT analytical instrumentation (e.g., NIR, FBRM Instruments, APC Software) for manufacturing campaigns: including preparation, installation, calibration, and performance checks. Monitor instrumentation output during campaigns using advanced process control software & real-time dashboards & analytics. Ability to work in a GLP or GMP environment with appropriate documentation and safety practices. 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

Requirements

• Bachelor’s Degree in Analytical Chemistry or related field, with 0 to 2+ years of R&D, engineering, or manufacturing experience.
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions & SOPs, and comply with company policies

Nice To Haves

• At least one year of experience in product development and analytical chemistry
• Experience with PAT instruments (NIR, FBRM), APC software, chemometrics, and/or data analysis in a GMP environment.
• Experience with interdisciplinary drug development teams, analytical instrumentation, and method development in a regulated (GMP/GxP) environment.
• Demonstration of interpersonal skills, teamwork, adaptability, innovation, and initiative

Responsibilities

• Utilize PAT analytical instrumentation (e.g., NIR, FBRM Instruments, APC Software) for manufacturing campaigns: including preparation, installation, calibration, and performance checks.
• Monitor instrumentation output during campaigns using advanced process control software & real-time dashboards & analytics.
• Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees