Drug Product Analytical Development Scientist

Eurofins USA PSS Insourcing Solutions

Drug Product Analytical Development Scientist

Groton, CT
Full Time
Paid
  • Responsibilities

    Job Description

    • Design and guide analytical strategies to support manufacturing process development.
    • Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment.
    • Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation.
    • Manage stability studies to assess degradation pathways and establish shelf-life parameters.
    • Develop impurity control strategies to ensure product quality and regulatory compliance.
    • Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
    • Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms.
    • Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
    • Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations.
    • Maintain compliance with GLP/GMP standard and safety protocols
  • Qualifications

    Qualifications

    • PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years
    • Strong oral and written communication skills.
    • Experience in a regulated laboratory environment (GLP/GMP).
    • Proven ability to lead scientific projects and mentor team members.
    • Proficiency in analytical instrumentation and techniques.
    • Familiarity with regulatory documentation and submission processes.

    Additional Information

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

  • Compensation
    $70,000-$70,000 per year