Method Validation & Transfer Scientist

Eurofins USA PSS Insourcing Solutions

Method Validation & Transfer Scientist

Sanford, NC
Full Time
Paid
  • Responsibilities

    Job Description

    ** Position Overview:**

    The resource will work at a client facility in Sanford, NC and will be a member of the Quality Control Portfolio Management team to support multiple quality programs. The resource will be able to analyze chemical, or biological or microbiological products. The resource should be able to perform the analytical or chemical or microbial and sterility testing in the GMP laboratory setting and should be able to collaborate efficiently with the external teams. Additionally, the candidate should be able to document all the data to in accordance with cGMP and data integrity principles. The resource should be able to review the validation data as a second analyst reviewer.

    ** Position Responsibilities:**

    • Independently plan and execute laboratory experiments.
    • Collaborate with trainers, colleagues and subject matter experts to perform the assays in the laboratories, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.
    • Assisting teams in completing the assays required for the validation and transfer of methods.
    • Engage with the method development team and participate in both in-process and final product sample analyses.
    • Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.
    • Prepare technical reports, critically review data as second analyst for the validations, and evaluate new instrumentation and analytical techniques as required.
    • Independently analyze experimental data and provide conclusive insights.
  • Qualifications

    Qualifications

    ** Basic Minimum Qualifications:**

    • BS+1 year of industry experience, preferably in GMP environment
    • Hands-on experience and strong background in either Chemistry, Microbiology or molecular biology assays.
    • Experience with troubleshooting assays and improving method performance.
    • Strong technical writing and presentation skills.

    ** Preferred Qualifications:**

    • Experience with method validation and method transfer skills to manufacturing site.
    • Experience with bio-process downstream development.
    • Resource is expected to be self-motivated and driven and able to manage day to day work activities with minimum direction.
    • Should have a positive and teamwork mindset.
    • Should be an analytical thinker and use their skills to troubleshoot the daily challenges faced at the workbenches, in data reviewing and documentation.

    Additional Information

    Position is Full Time, Monday-Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC **** are encouraged to apply.

    ** What we offer:**

    • 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
    • Yearly goal-based bonus & eligibility for merit-based increases

    Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.