Sr. Research Associate - Assay Transfer

Lancesoft; Tucson (AZ); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Lancesoft, based in Tucson, AZ, is seeking a scientist to support assay transfer from development to manufacturing, driving process characterization and manufacturing strategies to improve product manufacturability.

Ideal candidates hold a Bachelor’s degree with 6+ years of relevant experience or a Master’s degree with 1+ year, and have hands-on wet lab experience in IHC and ISH within regulated environments. Strong data analysis and proficiency with standard office tools are essential.

Qualifikationen

• Experience leading design and execution of lab experiments.
• Experience with process characterization and transfer activities.
• Knowledge of Design for Six Sigma and Design for Quality and Manufacturability (DQM) principles.

Aufgaben

• Lead lab protocol design and troubleshoot complex assays.
• Prepare manufacturing documentation and transfer activities for new products.
• Ensure quality standards and data integrity in laboratory work.

Kenntnisse

Wet lab techniques

IHC

ISH

Data analysis

Regulated environment experience

Ausbildung

Bachelor's degree in Science

Master's degree in Science

Tools

Word processing software

Spreadsheet software

Graphical/presentation applications

Jobbeschreibung

SUMMARY

As a member of the Assay Transfer team, you will facilitate the seamless transition of new and existing reagent products from Development to Manufacturing. This role involves initiating, directing, and executing process characterization, scientific research, and manufacturing process strategies to support product manufacturability and improve process capability.

Education & Experience

Bachelor s degree in Science with 6+ years of post-college relevant experience, OR Master s degree with 1+ year of relevant experience.

Technical Expertise

Hands-on experience with wet lab and biological techniques, specifically IHC (Immunohistochemistry) and ISH (In Situ Hybridization). Direct experience in a regulated environment, product development, and/or manufacturing operations. Proficiency in standard laboratory techniques, scientific literature retrieval, and software tools (word processing, spreadsheets, graphical/presentation applications).

Methodologies

Ability to apply Design for Six Sigma and Design for Quality and Manufacturability (DQM) principles to optimize processes and solve potential inventions or production issues.

KEY RESPONSIBILITIES & ESSENTIAL DUTIES

Laboratory Execution & Protocol Design: Lead the design, execution, and troubleshooting of complex laboratory protocols, bench experiments, process characterization, and scale-up activities with minimal supervision. Execute bench experiments, record meticulous observations, and conduct quantitative data analysis.

Process Transfer & Quality Standards: Prepare manufacturing documentation and complete transfer activities for new products. Champion "Quality First Time" standards while identifying and implementing process capability improvements in the laboratory environment.