Method Development and Validation Research Technician I

Eurofins; Lenexa (KS); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

401(k) with company match

Paid vacation

Résumé du poste

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support the Bioanalytical Method Development and Validation Team, overseeing scientific and operational management of client bioanalytical projects. Experience with method validation and transferring methods to the analytical team is essential.

The role requires knowledge of immunoassays, ELISA, and regulatory compliance with GxP, FDA, GLP, GDP, GCP, OECD, and CLIA. Excellent communication and teamwork are required.

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.

Responsabilités

• Performs the development, validation, and transfer of immunoassays and bioanalytical methods (including 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.
• 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.

Connaissances

Immunoassays

ELISA

Method validation

Transfer methods

Data reporting

Formation

B.S. degree

M.S. degree

Ph.D.

Outils

ERP

LIMS

MS Excel

MS Word

Description du poste

Company Description

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.

Company Description

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.

Job Description

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.

Research Technician I Duties Include but are not Limited to the Following

• 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.

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.
• Solid ELISA expereince
• 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 The Following

• 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, 8:00am - 4:30pm, and additional hours as needed. Candidates currently living within a commutable distance to Lenexa, KS are encouraged to apply.

• 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.