LC/MS Scientist - Extractables & Leachables at Eurofins USA BioPharma Services
Lancaster, Pennsylvania, USA -
Full Time


Start Date

Immediate

Expiry Date

17 Oct, 25

Salary

0.0

Posted On

18 Jul, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Sponsorship, Testing, Chemistry, Method Development, Authorization, Validation

Industry

Pharmaceuticals

Description

IN OVER 30 YEARS, EUROFINS HAS GROWN FROM ONE LABORATORY IN NANTES, FRANCE TO 58,000 STAFF ACROSS A DECENTRALISED 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

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

PREFERRED QUALIFICATIONS:

  • Experience operating GC/MS and/or ICP systems
  • Experience with Extractables and Leachables testing
  • Experience with ISO10993 and/or ISO18562 testing
  • Experience in a cGMP, GLP, and/or ISO17025 compliant/accredited lab
  • Experience with method development and validation
  • Experience identifying unknown compounds by mass spec
  • Polymeric experience/education

BASIC MINIMUM QUALIFICATIONS:

  • Bachelor’s degree or higher in Chemistry or related scientific discipline
  • At least 1 year of experience operating LCMS
  • Authorization to work in the US without sponsorship
    Additional Information
Responsibilities

Please refer the Job description for details

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