GMP Laboratory Analyst

Eurofins USA PSS Insourcing Solutions•Groton, CT

About The Position

Eurofins is seeking a detail-oriented and motivated analyst to support analytical and microbiological testing and laboratory operations in a GMP environment. The role includes water testing for manufacturing facilities and GMP release and stability testing of clinical drug substance and drug product throughout development. Testing may also support excipients, packaging, and post-packaging activities. The analyst will perform stability sample setup and analysis, and method development and validation for drug substance and drug product. The position is Monday through Friday, 8 a.m. to 5 p.m., with overtime as needed and possible weekend or holiday work based on business needs. Candidates within commuting distance of Groton, Connecticut, are encouraged to apply.

Requirements

  • Bachelor’s degree in science or a related degree concentration, or equivalent directly related experience.
  • Strong computer, scientific, and organizational skills.
  • Excellent oral and written communication skills and attention to detail.
  • Ability to work independently and as part of a team; self-motivated, adaptable, and positive.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Authorization to work indefinitely in the United States without restriction or sponsorship.

Nice To Haves

  • Experience in a GMP laboratory.
  • Experience with microbiology and analytical chemistry.
  • Experience with eLN, LIMS, and data trending.
  • Experience with GMP, microbiological testing, wet chemistry, HPLC, Raman, or FTIR.

Responsibilities

  • Perform total viable count testing, including filtration and pour plate, as well as appearance, coliform, and chlorine testing for water used in manufacturing facilities.
  • Use analytical methodologies, systems, and processes to support GMP release and stability testing of clinical drug substance and drug product throughout all development phases.
  • Perform testing that may include compendial testing for excipient and packaging release, disintegration, dissolution, HPLC/UPLC, SFC, generic testing, and compound-specific methods.
  • Set up and analyze drug substance and drug product stability samples.
  • Develop and validate analytical methods for drug substance and drug product.
  • Maintain accurate records and follow applicable documentation, safety, and company practices.

Benefits

  • Comprehensive medical coverage
  • Dental and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
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