Assay Characterization & Validation Consultant

Job Title: IVD Assay Characterization Validation Consultant Job Description We are seeking an IVD Assay Characterization Validation Consultant to lead the technical characterization, execution, analytical verification, and regulatory documentation for automated clinical chemistry processes. This role requires a hands-on scientist with a proven track record of transforming complex biochemical processes into scalable manufactured diagnostic products. The successful candidate will spearhead CLSI-compliant validation protocols, manage analyzer operations, lead multi-method matrix characterizations, and author technical packages for FDA Pre-Submissions Q-Sub. Responsibilities Author, review, and finalize formal clinical validation protocols in strict alignment with CLSI guidelines. Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrix applications. Design iterative experimental workflows to characterize precision, linearity, interferents, stability, and matrix dynamics. Lead hands-on operation, calibration, and execution on automated clinical chemistry platforms, specifically Roche Cobas systems. Perform complex multi-day evaluations, such as 20-day EP05 protocols, spike-and-recovery assessments, and serial dilution series. Mentor and train laboratory staff on platform SOPs, clinical protocols, and standardized analytical techniques. Spearhead method comparison studies evaluating candidate assays against primary and secondary reference standards. Investigate and resolve complex matrix phenomena, such as surface tension variations, fluidic behavior, and recovery bias in protein-free aqueous solutions. Conduct iterative assay characterization cycles to define Limits of Detection/Quantitation (LoD/LoQ) and Analytical Measuring Ranges (AMR). Perform statistical analysis on raw datasets using specialized validation software to build statistical models, recovery plots, and bias metrics. Draft comprehensive Method Validation Reports (MVRs) for inclusion in the Design History File (DHF) and regulatory filings. Compile analytical performance packages for FDA Pre-Submission Q-Sub documentation. Frame strategic technical and regulatory questions for FDA Q-Sub interactions regarding matrix expansion and validation scope. Essential Skills On-going Ph.D. or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related discipline. 2 years of experience in IVD assay development, characterization, and method validation within a regulated quality environment (FDA 21 CFR 820 / ISO). Deep practical knowledge of CLSI standard methodologies. Direct hands-on experience operating automated clinical chemistry analyzers; Roche Cobas experience strongly preferred. Working knowledge of FDA 510k matrix expansion strategies and the Q-Sub process. Additional Skills & Qualifications Demonstrated ability to bridge theoretical chemistry and commercial IVD manufacturing requirements. Strong practical troubleshooting capability on benchtop and automated platforms. Exceptional experimental discipline, data integrity, and attention to detail. Ability to distill complex analytical findings into actionable insights for scientific, engineering, and regulatory teams. Self-directed operator who thrives in a fast-paced, milestone-driven product development environment. Work Environment The role offers a flexible consulting/contract arrangement with a hybrid schedule, including three days on-site and two days remote, based in Indianapolis, IN. The work environment is dynamic, focusing on a large-scale commercial point-of-care IVD product launch. The position provides the potential for expanded technical leadership or long-term collaboration. Job Type & Location This is a Contract position based out of Indianapolis, IN. Pay and Benefits The pay range for this position is $53.00 - $53.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Indianapolis,IN. Application Deadline This position is anticipated to close on Sep 18, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.