Principal Scientist, Drug Product Analytical Development

Eurofins USA PSS Insourcing Solutions

Principal Scientist, Drug Product Analytical Development

Groton, CT
Full Time
Paid
  • Responsibilities

    Job Description

    • Work in a GLP or GMP environment with appropriate documentation and safety practices
    • Lead the development and execution of analytical strategies for new drug product candidates
    • Plan, direct, and review laboratory work, including method development, validation, and transfer
    • Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.
    • Develop impurity control strategies aligned with regulatory expectations.
    • Collaborate with formulations, process and regulatory teams to ensure seamless pharmaceutical drug development
    • Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate
    • Critically review and interpret scientific data to derive clear conclusions and provide direction for future work
    • Mentor and guide junior scientists in analytical techniques and data interpretation.
    • Evaluate and implement new strategies as needed, e.g. working with external partners
    • Communicate results and conclusions through various media including presentations and technical reports
    • Author relevant sections of the quality modules of regulatory submissions
  • Qualifications

    Qualifications

    • Ph.D. in Analytical Chemistry or related field, with 5-7+ years of pharmaceutical R&D experience, or B.S./M.S. with 15+ years of pharmaceutical R&D experience required
    • Authorization to work in the United States indefinitely without restriction or sponsorship
    • Proven expertise in a broad range of analytical techniques, e.g,. chromatography, mass spectrometry, dissolution, spectroscopy, NMR, and data analysis
    • Strong understanding of regulatory requirements and experience with regulatory filings
    • Experience with method transfer and working with external partners
    • Proficiency in scientific software, data systems, and modeling tools
    • Demonstrated leadership, problem-solving, and mentoring capabilities

    Desired Qualifications:

    • Experience with mathematical modeling or coding
    • Candidates currently living within a commutable distance of Groton, CT are encouraged to apply

    Additional Information

    • Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.
    • 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

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

  • Compensation
    $80,000-$80,000 per year