Job Description

Role Responsibilities:

• Utilize PAT analytical instrumentation (e.g., NIR, FBRM Instruments, APC Software) for manufacturing campaigns: including preparation, installation, calibration, and performance checks.
• Monitor instrumentation output during campaigns using advanced process control software & real-time dashboards & analytics.
• Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
• 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

Qualifications

Minimum Qualifications:

• Bachelor’s Degree in Analytical Chemistry or related field, with 0 to 2+ years of R&D, engineering, or manufacturing experience.
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions & SOPs, and comply with company policies
• Preferred Qualifications
• At least one year of experience in product development and analytical chemistry
• Experience with PAT instruments (NIR, FBRM), APC software, chemometrics, and/or data analysis in a GMP environment.
• Experience with interdisciplinary drug development teams, analytical instrumentation, and method development in a regulated (GMP/GxP) environment.
• Demonstration of interpersonal skills, teamwork, adaptability, innovation, and initiative

Additional Information

• Position is full-time, Monday - Friday 8am to 5 pm
• Ability to work overtime as required.
• Tasks require repetitive motion and standing for long periods of time.
• May be required to respond to off-shift operational issues.
• Candidates currently living within a commutable distance of Groton, NC 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
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• 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.