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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
ÂIn 2020, Eurofins generatedtotal revenues of EUR â‚ 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
This individual will be responsible for performing release, in-process, stability, and process characterization testing for our PSS client's Biologics late-stage clinical development and commercial programs in a cGMP compliant manner. This position will perform all activities according to approved written procedures or protocols. Additional responsibilities may include revision to SOPs, method validations, method transfers, and comparability assessments or bridging activities with new analytical methods required for INDa and BLA.
Essential Duties & Responsibilities
- Perform testing in accordance with written procedures for: drug substance and drug product clinical trial materials (bulk or packaged), stability samples, in-process samples, drug substance and drug product process characterization studies.
- Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices
- Processing of electronic data using procedures that ensure data integrity and security
- Ship samples to contract testing facilities
- Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations
- Transcribe results onto analysis reports
- Perform daily standardization and performance verifications on laboratory equipment
- Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security
- Identify deviations to written procedures. Write deviation investigation reports
- Disposal of laboratory waste on an as needed basis
- Identify and report unsafe conditions within the laboratory
- Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing and write investigation reports
- Write and review equipment qualification documentation
- Qualify as trainers on test method procedures. Execute and document training. Assist in the creation and implementation of laboratory training programs.
- Troubleshoot to ensure quality objectives are met
- Bachelor's degree in Chemistry, Biochemistry or related scientific field
- 1 - 2 years oflaboratory experience in a regulated environment
- Ability to perform routine analysis and operate laboratory equipment. Techniques preferred but not required are: HPLC, GC, SDS-PAGE, Capillary Electrophoresis, Karl Fisher, UV-Vis Spectrometry, and pH measurements
- Understands paperwork review process
- Practical experience with various types of laboratory instrumentation
- Troubleshooting skills with analytical methodology and instrumentation
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Wimington, OHare encouraged to apply.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
- 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