R&D Scientist II, Chemistry

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 lifecycle 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 higherlevel scientists as needed.
Provides training to other laboratory personnel in the execution of testing procedures.
Responsible for communicating businessrelated 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 processlevel 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:
Bachelors or Masters degree in Chemistry or a closely related field.

Years of Related Experience:
A Bachelors degree in Chemistry or a closely related field with more than 3 years of applicable experience or a Masters degree in Chemistry or a closely related field with 13 years of applicable experience including:
Experience in the medical device or other GxPregulated industry.
Handson 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 handson 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 GxPregulated industry and understanding of ICH QSR FDA and ISO guidelines is preferred.
Experience in validating or qualifying instruments in a GxPregulated industry is preferred.
Must possess effective oral and written communication skills and demonstrate the ability to function effectively in a crossfunctional team environment.
Experience working with detergents sterilants and disinfectants is preferred.
The successful candidate must be selfdriven have strong criticalthinking and problemsolving skills and be capable of working independently or in a team.

Responsibility for Others and Internal Interactions
Works effectively with crossfunctional teams.

External Interactions
Responds to questions from ASP customers government agencies or auditors according to standard operating procedures.
Supports communication with external suppliers service providers and manufacturers.

Travel on the Job: 0-10% Domestic

Compliance
All employees must comply with applicable laws regulations standards and ASP policies and procedures. This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of duties or responsibilities. Employees may perform other jobrelated tasks as assigned by their supervisor. Reasonable accommodations may be made for individuals with disabilities.