R&D Scientist II, Chemistry Advanced Sterilization Products Irvine, CA, Posted

Position: R&D Scientist II, Chemistry Advanced Sterilization Products Irvine, CA, United States Posted 6 [...]
## R&D Scientist II, Chemistry Irvine, CA, United States
** Position Summary
** The R&D Scientist II, Chemistry works under moderate supervision and uses knowledge of scientific techniques to contribute to the design and development of safe and effective company products in compliance with new product development procedures.
** Duties and Responsibilities
** Under moderate supervision and general direction, and in accordance with all applicable government laws, regulations, and ASP policies, procedures, and guidelines, this position:  
• Plans and executes experiments and project tasks in support of new technologies associated with cleaning, disinfection, or sterilization of medical instruments.  
• Demonstrates research and development techniques; independently determines how to set up and execute experiments and analyses.  
• Follows prepared protocols and designed experiments to execute research studies under limited supervision to support new product development from feasibility to final product verification/validation.  
• Performs routine and complex testing in compliance with laboratory test methods and procedures to support timely delivery of tasks related to new product development and product life‑cycle management.  
• Conducts qualitative and quantitative chemical analysis of raw materials and finished goods.  
• Develops appropriate protocols, executes studies, organizes data, performs data analysis, and prepares reports.  
• Supports the development of solutions to problems of limited to moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate action.  
• Participates in and supports new product development projects through feasibility work to pilot production.  
• Communicates experiment status and testing results effectively and comprehensively to others.  
• Supports and coordinates equipment qualifications and maintains laboratory instruments in their qualified state, as well as troubleshoots instrumentation in the event of issues.  
• Supports OOS, NC, and CAPA investigations for higher‑level scientists as needed.  
• Provides training to other laboratory personnel in the execution of testing procedures.  
• Responsible for communicating business‑related issues or opportunities to the next management level.  
• Performs other duties as assigned.
** Other Duties*
* • Provides support to other programs and project teams that require chemistry testing and technical expertise.  
• Supports teams focused on identifying and implementing process‑level efficiencies.  
• Contributes to building an extraordinary team environment.  
• Meets and ensures adherence to compliance standards, including monitoring and compliance with relevant guidance documents such as those from ICH, ISO, and FDA.  
• Provides initial review of data generated by peers and contract laboratories.
** Qualifications
* **
* Education:

** Bachelor’s or Master’s degree in Chemistry or a closely related field.
** Years of Related

Experience:

** A Bachelor’s degree in Chemistry or a closely related field with more than 3 years of applicable experience, or a Master’s degree in Chemistry or a closely related field with 1–3 years of applicable experience, including:  
• Experience in the medical device or other GxP‑regulated industry.  
• Hands‑on experience in a laboratory environment and analytical chemistry.
** Knowledge, Skills, Abilities*
* • Strong understanding of compliance with applicable laboratory and safety procedures is required.  
• Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing medical devices is preferred.  
• Knowledge and experience in formulation chemistry and design of experiments (DOE) is preferred.  
• Excellent hands‑on experience in an R&D chemistry laboratory is required.  
• Strong knowledge of analytical chemistry techniques is required.  
• Knowledge and experience in analytical method development, validation, and transfer is preferred.  
• Professional experience in a GxP‑regulated industry and understanding of ICH, QSR, FDA, and ISO guidelines is preferred.  
• Experience in validating or qualifying instruments in a…