About the role
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
Basic Minimum Education & Experience Qualifications:
* B.A. or B.S. with minimum 3-4 years method development and validation & ELISA experience * M.A. with minimum 2-3 years method development and validation & ELISA experience * Ph.D. with minimum 0-1 year method development and validation & ELISA experience
Basic Minimum Work Requirements:
* Experience in designing, validating, and/or performing immunoassays. * Solid ELISA expereince * 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.
* 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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Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.