GC/MS Scientist- Extractables & Leachables

Job Description

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. This individual will:

• 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 run 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

Qualifications

• Minimum Qualifications: 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
• Preferred Qualifications: 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

Additional Information

• Working schedule will be Full-Time, First Shift, M-F 8am-4pm
• Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply
• No relocation assistance will be given
• 25% travel may be required
• This position is NOT remote
• 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 Disabled and Veteran Equal Employment Opportunity employer.