Method Development and Validation Research Technician I

Eurofins USA Clinical Trial Solutions; Lenexa (KS); On-site; USD 70,000 - 95,000; Full time

Job summary

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support Bioanalytical Method Development and Validation, overseeing scientific and operational aspects of client bioanalytical projects across multiple studies. Requires knowledge of method validation and communication to transfer methods to the analytical team.

The role develops, validates, and transfers immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, Elispot), designs and manages

Qualifications

• B.A. or B.S. with 3–4 years method development and validation experience
• M.A. with 2–3 years method development and validation experience
• Ph.D. with 0–1 year method development and validation experience
• Experience in designing, validating, and/or performing immunoassays
• Pharma and/or CRO, Clinical Laboratory experience required
• Ability to read, write, and interpret SOPs, technical reports, and method protocols
• Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

• Develop, validate, and transfer immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, and Elispot)
• Design, plan, perform, and manage routine and non-routine projects with guidance
• Assist in evaluating manufactured products and develop fit-for-purpose assays
• Create validation plans, test methods, worksheets, preparation sheets, and deviation reports
• Compile data and collaborate with the Scientific Director for project progression
• Apply ERP, LIMS, and other IT systems as required
• Communicate project updates to internal teams and clients under supervision
• Work as part of a team and independently to meet deadlines
• Assist in assay re-qualification as needed
• Comply with GxP, FDA, GLP, GDP, GCP, OECD, and CLIA requirements
• Maintain safety and environmental health compliance

Skills

Immunoassays

Data analysis

MS Excel

MS Word

Statistical analysis

Troubleshooting

Time management

Communication skills

Education

B.A./B.S. in relevant field

M.A. in relevant field

Ph.D. in relevant field

Tools

ERP systems

LIMS

Instrumentation software

Job description

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 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.