GC/MS Scientist- Extractables & Leachables
Eurofins BioPharma Product Testing North America
Summary
The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds that may pose health risks to the patient.
Job description
- Perform various tasks and analyses of Bio/pharmaceutical ingredients and products with a high degree of accuracy and precision
- Review/prepare standards and samples for analysis and running a variety of equipment or instrumentation independently
- Troubleshoot and solve instrumental and/or method problems
- Work efficiently, proactively, and productively
- Ensure that client receives quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations
- Evaluate current systems and suggest process improvements when appropriate
- Write complete and detailed investigations independently
- Support multiple projects simultaneously
- Demonstrate leadership qualities and train newer analysts
Requirements
- Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration
- Authorization to work in the US indefinitely without restriction or sponsorship
- 1 year of GMP laboratory experience
- 1 year of experience with GC/MS in industry
- Experience operating GC/MS and/or ICP systems
- Experience with extractables and leachables testing
- Experience with ISO 10993 and/or ISO 18562 testing
- Experience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab
- Experience with method development and validation
- Experience identifying unknown compounds by mass spec
- Polymeric experience/education
Benefits
- Medical Coverage
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- 401(k) With Company Match
- Paid Vacation
- Paid Holidays
Company overview
Eurofins BioPharma Product Testing North America is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide, providing comprehensive laboratory services for pharmaceutical, biopharmaceutical, and medical device companies. As a leading Contract Research Organization (CRO), the company offers extensive testing capabilities for drug substances, final products, intermediates, and starting materials for both small and large molecule drug products. Operating under GMP authorization, ISO 17025 accreditation, and ISO 9000 certification, Eurofins performs analyses according to international pharmacopeial standards including Ph. Eur., BP, USP, and JP. With over 2 million square feet of global laboratory capacity spanning 20 countries and more than 45 locations worldwide, the company maintains seven key US sites in Lancaster, PA; Portage, MI; Columbia, MO; Cary, NC; Charlotte, NC; Jacksonville, FL; and San Diego, CA. Their comprehensive service portfolio includes method development and validation, release testing, stability testing, characterization testing, residuals and impurities testing, extractables and leachables testing, viral clearance studies, and cell and gene therapy testing. The company's harmonized quality procedures, centralized LIMS, and secure 24-hour data access via LabAccess.com provide clients with consistent, reliable testing services that support drug development from early stages through commercialization.