R&D Assay Integration and Production Scientist

Company: Hologic, Inc.
Location: San Diego
Posted on: May 3, 2025

Job Description:

Hologic is seeking an R&D Assay Integration and Production Scientist, responsible for designing and performing R&D feasibility experiments aimed at Assay development, Analytical and functional testing, and Reagent consumables integration.Duties & Responsibilities:

• Customize workflows to fit laboratory processes, integrate lab with lab instruments, visual inspection and QC tools.
• Ensure data integrity and seamless test management, inventory and sample tracking. Automates quality control and documentation, provides performance monitoring and troubleshooting.
• Design and perform complex experiments with minimal input from supervisor to support the project by performing assay development and functional testing, buffer formulation optimization, analytical and inspection methods development.
• Understands experimental goals within the context of the overall project. Independently analyzes data and summarizes experiments supporting a portion of the project. Where necessary, provide clear feedback and data presentations to other groups such as Software and Engineering/Assay Development on the outcome of the experiment.
• Accountable for the lab inventory and lab maintenance in compliance with 6S Operational Excellence standards. Performs instruments installation, maintenance, troubleshooting and training as well as coordinates shipments, orders and lab supplies.
• Collaborate and communicate effectively with peers and supervisors.
• Feasibility - Contributing to one or more of the following: sample processing or assay formulation experiments, working with data sets and data logs. Perform experiments to support feasibility of software such as results processing, change to the instrument, software protocols optimization and new instrumentation troubleshooting.
• Analytical and inspection methods - Development of quantitative and visual methods of product quality control, including fluorescence microscopy and fluorescent plate readers, biophysical and optical characterization; implementation of quantitative methods of analysis, statistical data analysis.
• Assay Integration - Executing experiments in one or more of the following areas:
  • Support data analysis processing or other software modules required to run the assay on the instrument.
  • Experiments to develop inspection methods and quality control quantitative methods.
  • Experiments to test assay performance at the extreme operating parameters of the instrument.
  • Experiments to transfer successfully an assay fully developed on one platform to another.
  • Experiments to improve assay or instrument robustness and ultimately performance.
  • Experiments to support product stability studies, as well as assay characterization and assay functional performance.
  • Functional testing - testing assay performance using qPCR.
  • Reagent Optimization and consumables integration - Designing and executing studies to support the optimum assay performance based on formulation.
  • Designing and executing studies based on inspection method development plan using the final version of the assay on a given platform. Generate documentation from these experiments to support regulatory submissions and or Marketing and Sales documents.
  • Product Development - Execute studies to support finalization of the product design, scale up for Manufacturing, finalization of software and hardware and planning for clinical studies. Examples of this might include but are not limited to setting specifications, Quality Reviews and supplying supporting documentation, Supporting RUO studies, contributing to writing software documents SRS, supporting hardware and software changes, and testing Development Lots.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
    • Demonstrate drive and commitment: shows reliability and commitment amongst manager and peers; exhibits focus and determination in tasks at hand; establishes support for objectives; drives and produces results.
    • Work efficiently and effectively: effectively manages time and priorities by focusing on highest priority tasks and working efficiently; effectively recovers from mistakes; completes projects on time.
    • Team membership: interacts in a team environment based on shared values; knows when and how to use a team approach to solve problems; seeks the contributions of all team members; shares credit with others.
    • Adapt and learn: works efficiently in situations involving ambiguity, shifting priorities and rapid change; demonstrates resilience and composure in difficult circumstances; deals constructively with mistakes and setbacks and learns from them; continually learns to grow and improve skills to meet organizational goals.Education:
      • B.S./M.S. Engineering, Chemical Engineering, Bioinformatics, Chemistry, Biochemistry, Molecular Biology or related field.Experience:
        • 5-7 years laboratory experience post-baccalaureate. Industrial experience preferred.
        • 3-5 years post-M.S. without thesis experience. Industrial experience preferred.
        • 2 years laboratory experience post-M.S. with thesis. Industrial experience preferred.
        • Preferred areas of industrial expertise:
          • LIMS (Laboratory Information Management System)
          • 6S Operational Excellence, Compliance with safety and quality regulations
          • Benchmark best practices across teams and industries
          • Problem-solving initiatives using Lean, Six Sigma or other methodologies
          • Contribute to writing SOPs, transfer reviews and specification settings
          • Proficiency in equipment operation and training junior research personnel
          • Experience in instruments maintenance and troubleshooting
          • Core Services - e.g. working in clean room environment, chemical engineering skills, analytical chemistry, biochemistry and molecular biology, qPCR skills, fluorescence microscopy, biophysical characterization and spectroscopy
          • Other areas:
            • Bioinformatics, Programming skills and statistical data analysis, JMP data analysis
            • Design of Experiments (DoE), HTS (high-throughput screening)The annualized base salary range for this role is $84,100 to $131,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.Why Hologic?We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.If you have the right skills and experience, apply today!#LI-RF1 #Mid-level
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Keywords: Hologic, Inc., San Diego , R&D Assay Integration and Production Scientist, Professions , San Diego, California