Method Development and Validation Research Technician I

E

Eurofins USA Clinical Trial Solutions

Method Development and Validation Research Technician I

Lenexa, KS
Full Time
Paid
  • Responsibilities

    Job Description

    The Scientist I will support the Bioanalytical Method Development and Validation Team and is responsible for the overall scientific and operational management of client bioanalytical projects supporting a variety of studies simultaneously. This role requires knowledge of method validation principles and communication skills required to transfer methods to the analytical team.

    ** Research Technician I Duties Include but are not Limited to the Following:**

    • Performs the development, validation, and transfer of immunoassays and bioanalytical methods (including but not limited to ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, and Elispot)
    • With guidance, designs, plans, performs, and manages routine and non-routine projects.
    • Assists in the evaluation of manufactured products and develops fit-for-purpose assays.
    • Creates technical documents in the form of validation plans, test methods, worksheets, preparation sheets, and deviation reports for review by the Scientific Director.
    • Compiles data and collaborates with the Scientific Director for project progression.
    • Applies use of IT systems (ERP, LIMs, etc.) as required.
    • Communicates project updates to internal team and external clients under direction supervision.
    • Works effectively as a member of a team as well as independently to achieve client and business deadlines.
    • Assists in assay re-qualification as needed.
    • Demonstrates and promotes the company vision.
    • Maintains regular attendance and punctuality.
    • Performs other duties as assigned.
    • Provides cross-functional support to other departments as needed.
    • Adjusts work hours as needed to meet client deadlines.
    • Understands and follows all procedures and processes required for work performed under Regulatory Compliance (e.g., GxP, FDA, GLP, GDP, GCP, OECD, and CLIA) and attends annual GLP training.
    • Complies with internal and customer SOP’s as required.
    • Conducts all activities in a safe and efficient manner by adhering to site environmental health and safety (EHS) requirements.
  • Qualifications

    Qualifications

    ** _Basic Minimum Education & Experience Qualifications _:__**

    • B.A. or B.S. with minimum 3-4 years method development and validation experience
    • M.A. with minimum 2-3 years method development and validation experience
    • Ph.D. with minimum 0-1 year method development and validation experience

    ** _Basic Minimum Work Requirements _:__**

    • Experience in designing, validating, and/or performing immunoassays.
    • Previous Pharma and/or CRO, Clinical Laboratory experience required.
    • Ability to read, write, and interpret documents such as SOPs, technical reports, and method protocols.
    • Authorization to work in the United States indefinitely without restriction or sponsorship.

    _ The Ideal Candidate Possesses the Following:_

    • Good communication and interpersonal skills.
    • Proven ability to compile data and create data reports.
    • Computer proficiency in MS Word, Excel, and instrumentation software.
    • Ability to perform statistical analysis and data interpretation.
    • Ability to solve practical problems and troubleshoot assays.
    • Ability to multitask with good time management.
    • Organizational skills to manage and prioritize multiple projects effectively under little supervision.
    • Proven ability to effectively communicate orally and in writing to coworkers, supervisors, and clients.
    • Have a positive attitude and genuine interest in the drug discovery and development process and impact to patient health.
    • Ability to work in a laboratory setting meeting the physical requirements of laboratory experiments.

    Additional Information

    Position is full-time working Monday - Friday, 8:00am - 4:30pm, and additional hours as needed. Candidates currently living within a commutable distance to Lenexa, KS are encouraged to apply.

    • Location: 15 Research Park Dr., St. Charles, MO 63304
    • 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

    Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.