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Pathogen Safety Scientist

Eurofins USA PSS Insourcing Solutions

Pathogen Safety Scientist

Holly Springs, NC +1 location
Full Time
Paid
  • Responsibilities

    Job Description

    POSITION SUMMARY:

    The Pathogen Safety Scientist will be responsible for performing multiple tasks within the Process Development group in support of biologics manufacturing process. The Scientist will perform a variety of responsibilities in both a team and individual setting. This position is a remote position.

    POSITION RESPONSIBILITIES:

    • Design and conduct virus validation studies and develop dedicated as well as contributing virus elimination steps in manufacturing processes
    • Develop experimental study designs in consultation with Client employees
    • Guide study personnel in the conduct of virus validation studies
    • Preparation of (GLP) study documentation (protocols, reports)
    • Plan and conduct experimental work including data analysis and communication of results to Client project team in the form of a report or presentation
    • Control and maintain biological systems (cell culture work, virus, and cell strain maintenance)
    • Perform viral titrations to determine viral titers under L2/S2 (and L3/S3) conditions.
    • Perform various analytical methods (protein determinations, pH measurements, etc.)
    • Operation of complex instruments and processing/preparation of raw data
    • Collect, prepare, and distribute samples/data in coordination with other departments
    • Participation in local and global projects
    • Create and maintain records within internal documentation systems
    • Create and revise technical documents, including operating procedures, test, or process protocols, and reports
    • Assist in the procurement of new equipment and systems
    • Maintain laboratory equipment according to specific quality standards (e.g., GLP)
    • Coordinate availability of materials, solutions, and reagents
    • Storage, retrieval of original documentation in a warehouse
    • Maintaining stock lists / database
    • Scanning of documents in Saperion
    • Inventory check, destruction, and documentation
    • Carrying out and documenting GLP tests in the laboratory e.g. spike tests, virus titrations, etc. according to the current test plans / SOPs
    • Maintenance of laboratory systems e.g., cell banks, virus stacks, reagents, equipment
    • Timely completion of test documents (test plans, GLP final reports) and other GLP relevant documents e.g., analytical test protocols, buffer preparation protocols
    • Supporting the study director in the drafting of study documents, if necessary
    • Preparation, review, and training of SOPs for the laboratory area
  • Qualifications

    Qualifications

    BASIC MINIMUM QUALIFICATIONS:

    • BS degree in biological or related sciences
    • Science background
    • Familiarity with USP, EU guidelines
    • Effective oral and written communications
    • Strong problem-solving skills
    • Ability to support outside standard hours

    PREFERRED QUALIFICATIONS:

    • At least 3 years of experience in science
    • Pathogen safety experience
    • Background with regulatory landscape
    • Ability to network

    Additional Information

    Position is Full Time, Monday – Friday First Shift with occasional support globally outside standard hours. Although a remote position, candidates currently living within a commutable distance of Bradley , IL 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.

  • Locations
    Bradley, IL • Holly Springs, NC