GMP Laboratory Analyst

Job Description

We’re seeking a detail-oriented and motivated individual to support analytical & microbiological testing, and lab operations in a GMP environment. This role involves performing TVC, Appearance, Coliform and Choline microbial testing and GMP analytical testing. The ideal candidate has hands-on analytical and microbiology experience, strong documentation skills, and thrives in a fast-paced, team-oriented setting.

• Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
• Experience with GMP, microbiological testing, wet chemistry, HPLC, Raman, FTIR
• Responsible for water testing in support of manufacturing facilities including total viable counts (including filtration and pour plate), appearance, coliform and chlorine testing.
• Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post-packaging support.
• Analytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV), and compound-specific methods.
• Set up and analysis of drug substance and drug product stability samples.
• Method development and validation of analytical methods for drug substance and drug product 

Qualifications

• Bachelor’s degree in science or other related degree concentration, or equivalent directly related experience. 
• Strong computer, scientific, and organizational skills.
• Experience with eLN, LIMS, and data trending.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Preferred Qualifications:

• Experience in a GMP laboratory, microbiology and analytical chemistry preferred.
• Experience with eLN, LIMS, and data trending.

Additional Information

• Position is Monday-Friday, 8-5. Overtime as needed 
• May be requested to work on weekends, overtime, and holidays based on business needs
• Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.
• 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
• #LI-EB1
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.