Method Development and Validation Research Technician II
Eurofins
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Benefits offered by this job
Job summary
Eurofins USA Clinical Trial Solutions is seeking a Method Development and Validation Research Technician II to support bioanalytical projects. This full-time role involves developing, validating, and transferring immunoassays and other bioanalytical methods, with direct client communication and documentation responsibilities.
The candidate will organize workflows, ensure GMP/GLP compliance, and mentor junior staff while contributing to timely, high-quality study delivery in a dynamic lab
Qualifications
- Pharma/CRO lab experience and regulatory knowledge (GxP, FDA/GLP).
- Experience designing and validating bioanalytical methods.
- Ability to manage client projects and timelines.
- Strong communication with internal and external clients.
Responsibilities
- Develop, validate and transfer immunoassays and bioanalytical methods (RIA, EIA, Flow Cytometry, Cell-Based).
- Provide contracted method development with timely delivery and high quality.
- Communicate project updates to clients with limited supervision.
- Produce validation plans, reports and deviation reports.
- Organize daily workflow to meet validation timelines.
- Mentor and train junior staff; provide technical leadership.
- Ensure GMP/GLP compliance and follow SOPs.
- Support multiple client studies with cross-functional teams.
Skills
Education
Tools
Job description
Full-time
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
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.
- 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
- B.A. or B.S. with minimum5-7 yearsmethod development and validation experience
- M.A. with minimum3-5 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.
- 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
- 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.
- Have a positive attitude and genuine interest in the drug discovery and developmental process and impact to patient health
Position isfull-time working Monday - Friday, 8:00am - 4:30pm, andadditional 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.
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