Method Development and Validation Research Technician II

Job Description

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.

Duties

• 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
• Reviews and troubleshoots method design and provides assistance
• 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
• 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

Qualifications

• Basic Minimum Education & Experience Qualifications: 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
• Basic Minimum Work Requirements: 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

The Ideal Candidate

• Possesses excellent communication and interpersonal skills
• 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
• 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 developmental process and impact to patient health

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.