GCMS Scientist Extractables Leachables

Eurofins USA BioPharma Services; Lancaster (Lancaster County); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Lancaster, PA, is seeking an Extractables & Leachables Analyst to support evaluation of container closures, delivery systems, and medical devices for extractables and leachables. The role focuses on preparing samples, analyzing components, and ensuring data quality under GMP/GLP guidelines, while contributing to process improvements.

Ideal candidates hold a Bachelor's degree in a chemistry-related field, have US work authorization, and possess at least 1 year

Qualifications

• Bachelor's degree in chemistry, biology, biochemistry, or related field.
• US work authorization without sponsorship.
• 1 year of GMP laboratory experience.
• 1 year of GC/MS experience in industry.

Responsibilities

• Perform analyses of bio/pharmaceutical ingredients and products with high accuracy.
• Review/prepare standards and samples for analysis; operate instrumentation independently.
• Troubleshoot instrumental/method problems and maintain systems.
• Work efficiently, proactively, and productively.
• Review laboratory data for accuracy and GMP/GLP compliance.

Skills

GC/MS experience

Analytical lab skills

Education

Bachelor's degree in chemistry, biology, biochemistry, or related field

Tools

GC/MS / ICP systems

Job description

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 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

Qualifications

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.