Method Development and Validation Research Technician II

Eurofins•Lenexa, KS

14h•Onsite

About The Position

The Scientist II 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 analytical team. The Scientist II role supports client projects with limited supervision and requires project leadership and direct client communication.

Requirements

B.A. or B.S. with minimum 5-7 years method development and validation experience
M.A. with minimum 3-5 years method development and validation experience
Ph.D. with minimum 2-4 years method development and validation experience
Previous Pharma and /or CRO, Clinical Laboratory experience required.
Experience in designing and performing ligand binding assays.
Experience with operational process improvement programs.
Experience with direct client contact in industry
Authorization to work in the United States indefinitely without restriction or sponsorship.
Ability to perform statistical analysis and data interpretation
Computer proficiency in MS Word, Excel and instrumentation software.
Proven ability to compile data and create data reports
Ability to work in a laboratory setting, meeting the physical requirements of laboratory experiments.
Ability to read, write and interpret documents such as standard operating procedures and technical reports
Ability to solve practical problems and troubleshoot assays
Ability to multitask with good time management
Organizational skills to manage multiple priorities
Proven ability to effectively communicate orally and in writing to coworkers, supervisors, and clients.

Nice To Haves

Excellent communication and interpersonal skills
Have a positive attitude and genuine interest in the drug discovery and developmental process and impact to patient health

Responsibilities

Works effectively as a member of a team, under minimum direction, to achieve client and business deadlines
Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and attends annual GLP training
Assists the development, validation and transfer of immunoassays and bioanalytical methods with limited direct supervision (RIA, EIA, Flow Cytometry, Cell-Based Assays)
Provides contracted method development and validation services consistently with delivery on time and high quality.
Characterizes antibodies and performs reagent qualification as applicable
Conducts evaluation of manufactured products and develops fit-for-purpose assays
Communicates project updates to internal and external clients with limited supervision
Provides technical documentation in the form of validation plans, reports, deviation reports, test methods and tables with limited supervision
Reviews validation data, validation plans and reports and provides technical leadership and constructive feedback to team members
Has the ability to organize daily workflow of the development and validation schedule in lab and consistently meets validation timelines.
Ability to develop a method with assistance from Scientific Director
Provides technical leadership, mentoring and training to junior staff
Provides troubleshooting, root cause analysis and assistance with method design
Complies with internal and customer SOP’s as required in training program; maintains an up to date training file
Applies use of IT systems (ERP, LIMS, etc.) as required
With minimum guidance, designs, plans and performs/manages routine and non-routine projects
Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position
Owns the accountability and responsibility for delivering to client needs and timelines
Provides cross-functional support to other departments as required
Adjusts work hours as needed to meet client deadlines
Adheres to site environmental health and safety (EHS) requirements
Demonstrates and promotes the company vision
Regular attendance and punctuality
Performs other duties as assigned