What are the responsibilities and job description for the Extractables and Leachables Principal Scientist position at Eurofins USA BioPharma Services?
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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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.
Job Description
- Performing a large variety of analytical tasks involved in extractables and leachables projects including the development and validation of analytical methods used in the leachable testing of drug products by means of various procedures including HPLC/UV, HPLC/MS GC, GC/MS, and ICP-OES
- Reading, understanding, and interpreting diverse analytical procedures presented in a variety of written styles
- Utilizing technical knowledge in the development of unique analytical methods (including researching projects via literature and internet)
- Performing unknown compound investigations utilizing mass spectrometry, working independently and efficiently
- Documenting work clearly and performing tests accurately
- Contacting clients on a routine basis and being responsible for some projects
Qualifications
Minimum Qualification:
- Bachelor's in Chemistry or related science with minimum of 5 years of E/L experience.
- Understanding of regulatory expectations for E/L studies on medical devices and experience designing scientifically sound E&L studies.
Additional Preferences:
- Experience with ISO 10993 and/or ISO 18562 testing
- Participation in industry working groups (e.g., AAMI, USP, ISO, etc.)
- Experience with PFAS testing - MS or PhD in chemistry or related science
- Experience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab.
- Experience operating LC/MS, GC/MS and/or ICP systems.
- Experience with method development and validation.
- Authorization to work in the US without sponsorship.
Additional Information
Position is Part-Time, Monday – Friday with flexible start and end times. Located in Lancaster, PA open to remote for experienced candidate.
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 BioPharma Services is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
