Method Development and Validation Research Technician I

About the Role

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.

Key Responsibilities

• 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 SOPs as required.
• Conducts all activities in a safe and efficient manner by adhering to site environmental health and safety (EHS) requirements.

Requirements & Tech Stack

• Method development and validation
• ELISA
• Immunoassays
• IT systems (ERP, LIMS)
• Regulatory Compliance (GxP, FDA, GLP, GDP, GCP, OECD, CLIA)
• EHS requirements
• MS Word, Excel, and instrumentation software

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.
• Strong ELISA experience.
• 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:

• 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, 8:00 am - 4:30 pm, and additional hours as needed.
• Location: 15 Research Park Dr., St. Charles, MO 63304