The role
Become part of our Product Development team and help us to design and conduct feasibility studies investigating and optimizing the interactions among reagents, consumables, hardware and protocols. You will be able to use statistical methods to evaluate data, identify trends and make clear recommendations based on data. You will interface with a cross-functional project team to ensure alignment with design requirements and that the product meets approved quality standards. You will maintain detailed documentation throughout all phases of product development, and provide technical input for FMEAs, risk mitigation strategies and designs.

Responsibilities

• Assay characteristics of reagents and consumables, including both objective and performance criteria
• Troubleshoot hardware and software protocols and sources of variability derived from both reagents and consumables
• Formulate test batches of reagents for experimental use and performance characterization.
• Contribute to formulation of production lots of reagents following defined Work Instructions and completing batch records
• Perform acceptance tests on production batches of reagents and consumables
• Preparation of specific reagents and consumables for daily experimentation and performance characterization
• Analyze data using analytical tools (e.g., Excel, Python, R, ImageJ), documenting and presenting results to the team
• Create, track, monitor, and report metrics and key performance indicators for DNA Script instrument systems
• Perform system and subsystem verification and validation protocols
• Manage reagent stability study design, and execution. Investigate alternate materials to enhance reagent stability and/or improve system design/performance
• Troubleshoot and optimize fluidic dispense systems, thermal control systems and related subsystems.
• Develop and document acceptance / verification tests as required.
• Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records
• Define and develop performance-oriented feasibility studies for procedure improvements and newly implemented capabilities within the context of prototype development and improvement of finished products
• Execute and report the results of end-to-end experimental runs, including oligo design, run setup, observation of runs-in-progress, performance of a variety of molecular QC assays (qPCR, gel electrophoresis, NGS), data analysis and reporting of single data sets or trends across long term studies.

Essential

• BS in Biological Sciences or Engineering with 5+ years of experience in the Life Science and laboratory automation domain
• Strong skills in laboratory and system feasibility experimentation and Verification and Validation execution, Data Analysis, representation, and presentation, reagent formulation and GLP/GMP documentation.
• Desire and ability to work in a small interdisciplinary team to develop new technologies at a rapid pace.

Desirable

• Experience in regulated Life Science product/medical device development under design controls is preferred
• Knowledge of liquid handling and laboratory automation, microfluidics, molecular assay and QC techniques, and reagent and platform manufacturing techniques is preferred.
• Demonstrated problem-solving and troubleshooting skills along with strong verbal and written communications
• Organized and detail oriented
• Ability to work in a team environment

Miscellaneous

• Job located in South San Francisco
• Start date: ASAP
• Contact: cdm@dnascript.co