ELISA Associate Scientist - Eurofins Lancaster Laboratories Professional Scientific Services, LLC

Company 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.

Job Description

• Design and Execution of laboratory experiments to support development, validation and transfer of analytical methods for monitoring process related impurities (ex. Host Cell Proteins, residual ProA, DNA) in Biologics. Author, review and/or approve technical documents or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods (protocols, reports, test methods, regulatory filings, etc). Evaluation / Implementation of new technologies.
• Able to work independently with minimal supervision. Competent in multiple analytical techniques with advanced knowledge in at least one relevant technique (plate based assays, ELISA, qPCR, western blot/gel-electrophoretic methods).

POSITION ACCOUNTABILITIES

• Development, validation and transfer of analytical impurity methods to support Biological product release (60%)
  • Execution of laboratory experiments to support development and validation of analytical methods for process related impurities for Biologics programs.
  • Planning, designing, and conducting experiments and data analysis to support the development and validation of process related impurity methods.
  • Supporting troubleshooting and assay remediation activities with strong technical expertise in plate based impurity methods and fundamental understanding of analytical development principles.
  • Support in the lab or oversee characterization of critical reagents (Antibodies, conjugated antibodies, assay controls, calibration standards) using a variety of fundamental biochemical methods including ELISA, 1 and 2 D gel electrophoresis methods, western blot, HPLC and LCMS methods and protein concentration determination.

• Author, review and/or approve technical documents (protocols, reports, test methods, etc) or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods related to Biologics (30%)
• Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and participating in cross functional meetings.
• Responsible for maintaining awareness of current regulatory guidelines that may apply to methods being validated (ICH quality guidelines etc).

Qualifications

Degree in Chemistry, Biochemistry, Biology or other related discipline with minimum additional years of relevant industry experience in Analytical Development or related function:

• BSc and 3-4 yrs industry experience
• MSc and of 1-2 yrs industry experience

Key areas of expertise and competencies:

• Hands on experience working on development of plate based impurity methods including process specific host cell protein (HCP) ELISA, residual DNA methods (qPCR, dPCR), residual Protein A methods, Octet methods and related technologies.
• Experience in overseeing or performing critical reagent generation, characterization and qualification for use in Process related impur