Scientist II: Method Development & Validation
- Employer
- Eurofins Lancaster Laboratories
- Location
- 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.
- 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.
- 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
- 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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