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Scientist II: Method Development & Validation

Eurofins Lancaster Laboratories
Saint Charles County, MO
Closing date
Jan 25, 2022

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Job DescriptionThe 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.
  • 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.
QualificationsThe Ideal Candidate would possess:
  • 2-4 years relevant work experience in laboratory setting
  • Experience in designing, validating, and/or performing immunoassays
  • Good communication and interpersonal skills.
  • Ability to read, write, and interpret documents such as SOPs, technical reports, and method protocols.
  • Ability to perform statistical analysis and data interpretation.
  • Proven ability to compile data and create data reports.
  • 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.
  • Computer proficiency in MS Word, Excel, and instrumentation software.
  • 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.
Basic Minimum Qualifications
  • B.A., B.S., or M.A. required.
  • Previous Pharma and/or CRO, Clinical Laboratory experience
  • Authorization to work in the United States indefinitely without restriction or sponsorship
Additional InformationPosition is full-time, Monday - Friday 8:00am - 4:30pm. Candidates currently living within a commutable distance of St. Charles, MO 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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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