Process Analytical Technology Associate

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:

• Bachelors 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
• #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.

Remote Work :

No

Employment Type :

Full-time