Senior Assay Development Scientist Jobs in Indiana

Research and Development Scientist

Position Overview: We are seeking a talented Research & Development Scientist to join our toxicology laboratory team in Indianapolis, IN. This position is responsible for the research, development, validation, and continuous improvement of testing methods used to detect drugs of abuse in urine and oral fluid specimens. This role works independently to design and execute method development studies across EMIT immunoassay and LC-MS/MS platforms, applying extraction techniques including liquid-liquid extraction, crash and shoot, and dilute and shoot. The R&D Scientist collaborates closely with the Scientific Director, Laboratory Manager, and Quality Assurance team to bring new methods into compliant, production-ready use and to troubleshoot and optimize existing assays.

Reports to: Scientific Director

Key Responsibilities:

Method Development & Validation

· Assay Development: Designs, develops, and validates new testing methods for drugs of abuse in urine and oral fluid specimens using EMIT immunoassay and LC-MS/MS platforms.

• Extraction Techniques: Applies and refines extraction methods, including liquid-liquid extraction, crash and shoot, and dilute and shoot, in support of method development.

• Instrumentation Expertise: Applies working knowledge of Agilent and Waters LC-MS/MS platforms to method development and troubleshooting.

• Validation Studies: Designs and executes validation studies (e.g., precision, accuracy, linearity, specificity, stability) to support new and modified test methods, documenting results in accordance with regulatory standards.

Process Improvement & Troubleshooting

· Assay Optimization: Continuously evaluates existing methods to identify opportunities for improved sensitivity, specificity, turnaround time, or cost efficiency.

· Technical Troubleshooting: Serves as a technical resource to production laboratory staff, investigating and resolving instrument or method-related issues that affect testing quality or turnaround time.

· Root Cause Analysis: Leads root cause investigations for method-related failures, QC exceptions, or unexpected results, and develops corrective/preventive action plans.

Documentation & Compliance

· SOP Development: Authors and maintains Standard Operating Procedures (SOPs) for new and existing test methods in coordination with the Scientific Director and Quality Assurance team.

· Regulatory Compliance: Ensures all method development and validation work complies with applicable regulatory and accreditation standards (e.g., CLIA, CAP- FDT).

· Technical Documentation: Maintains detailed records of experiments, validation studies, and method changes to support audits, inspections, and litigation requests as needed.

Collaboration & Communication

· Cross-Functional Coordination: Works closely with the Scientific Director, Laboratory Manager, and Certifying Scientists/Supervisors to transition validated methods into routine production use.

· Technical Guidance: Provides technical training and guidance to laboratory staff on new methods, instrumentation, or procedural changes.

• Reporting: Prepares technical reports and presentations summarizing method development and validation findings for internal stakeholders.

• New Testing Opportunities: Works with the Scientific Director to evaluate new testing opportunities based on the needs of the company and clients.

Qualifications:

Education & Experience:

· Education: Bachelor's degree in Chemistry, Biochemistry, Toxicology, Forensic Science, or a related science field required.

· Experience: 3+ years of laboratory experience in a toxicology, forensic, or clinical laboratory setting, including hands-on experience with LC-MS/MS method development and validation.

Knowledge, Skills, and Abilities:

· Instrumentation Proficiency: Hands-on experience with Agilent and/or Waters LC-MS/MS platforms strongly preferred; experience with EMIT immunoassay technology required.

· Extraction Techniques: Demonstrated experience with liquid-liquid extraction, crash and shoot, and dilute and shoot sample preparation methods.

· Analytical Skills: Strong understanding of analytical chemistry principles, method validation protocols, and troubleshooting techniques.

· Regulatory Knowledge: Familiarity with CLIA, CAP- FDT, and other relevant regulatory/accreditation standards.

· Communication Skills: Strong written and verbal communication skills, with the ability to author technical documentation and present findings clearly.

· Independence & Initiative: Ability to work independently, manage multiple projects, and drive method development work from concept through validation.

Physical & Environmental Requirements:

· Ability to move around the lab, perform standing tasks, and occasionally lift light to moderate weights.

· Work in a laboratory setting with potential exposure to laboratory chemicals, equipment, and other operational conditions. #LAB123