Scientist I/ Scientist II, Validation

Genalyte•San Diego, CA

About The Position

We are seeking a Scientist II to lead our Development & Validation operations and provide expertise across our organization on performing, developing and validating hematology, serology, and chemistry assays. In this role, you will lead with groups in R&D, Quality, Regulatory and Manufacturing. In addition to overseeing daily operational activities, you will play a significant role in product development including leading GLP studies for FDA submissions and contributing to resolving design transfer and quality control challenges. You will also participate in research collaborations internally and with external partners. This posting is intended to fill two open positions.

Requirements

A minimum of a Master’s degree in chemistry, biochemistry or similar with 5+ years of experience in Assay Development
Experience with team direction and mentorship
Experience with FDA and 510(k) submission process
Experience in some or all of the following areas: Antibody and protein biochemistry, surface energy modification, assay development
Experimental design (DOEs, etc), statistical analysis, power analysis, and detailed understanding of precision, uncertainty, error propagation, etc. ○ 510(k) submissions and study requirements, verification and validation of assay designs
Chemical kinetics, silicon photonics, microfluidics
Experience with large data sets & analysis & software (jmp, minitab or similar)
Working with quality assurance and quality control teams
Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)
Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.)
Experience with protein or small molecule conjugation techniques, particle chemistry, particle size analysis and flow cytometry.
Experience with development of in vitro diagnostic for biomarkers in the Point of Care setting
Demonstrated skills in carrying out innovative research with minimal guidance in an accurate, effective manner
Proven ability to functionally direct junior research staff
Experience identifying and implementing new technologies or improvements of existing technologies for any of the following: marker discovery, marker validation, product development, DFM and product manufacturing
Knowledge of scientific principals and concepts
Excellent organizational skills and ability to manage multiple tasks/projects simultaneously
Ability to plan and execute experiments to prove feasibility, develop new processes and set specifications, characterize materials and set specifications, and troubleshoot problems
Demonstrated ability to consistently meet proposed objective timelines, apply competent use of project planning and project management skills
Knowledge of quality system regulations and processes
Understand theoretical basis for analytical instrumentation
Detail-oriented and able to work with a variety of people on multiple tasks, with effective prioritization of duties
Experience identifying and implementing new technologies for marker discovery, marker validation, product development, and product manufacture is also important
Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
General presentation & spreadsheet analysis software
Mathematical curve fitting packages
Statistical analysis software and routines

Responsibilities

Draft and finalize protocols and reports for analytical studies
Lead the existing team with strong competencies in serology, chemistry and other immunoassay practices and execution of controlled performance studies
Design, develop and optimize quantitative immunoassays for submission to the FDA for 510(k) clearance assessing feasibility through initial phases and through the design control process
Analyze data for assay and process improvement and report findings to team and senior leadership
Investigate and troubleshoot problem areas to recommend product improvements
Meet milestones for product development timelines
Work as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel
Maintain compliance with all company policies, quality systems, design control and procedures
Document results, protocols, SOPs, etc
Manage external studies in collaboration with key opinion leaders (KOLs) and support scientific publications
Oversee collaborations with clinical trial partners, study sites, and contribute to any and all internal documents
Actively communicates project status, challenges, concerns, and resource constraints to area management
Writes design control documentation and executes/oversees associated test and risk management activities
Works with R&D to develop, optimize and integrate assay V&V
Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed
Supports improvement verifications, validations, and transfers
Develops, reviews, or approves execution protocols and group generated data
Oversee studies, reviews protocol execution, and approves summary reports