Scientist II, R&D Chemistry
Scientist II, R&D Chemistry
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Job Description
Position Summary:
The Scientist II Chemistry works under moderate supervision and uses knowledge of scientific techniques to contribute on design and development of safe and effective company products in compliance to 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/project tasks in support of new technologies associated with cleaning and disinfection or sterilization of medical instruments.
- Demonstrates research and development techniques; independently determines how to set up and execute experiment and analysis.
- Follows prepared protocols and designed experiments to execute research studies under limited supervision to support product development from feasibility to final product verification/validation.
- Performs routine and complex testing in compliance with laboratory test methods and procedures to supporttimely delivery of the tasks related to the new product development and product life cycle management.
- Conducts qualitative and quantitative chemistry analysis of raw materials and finished goods.
- Develops appropriate protocols executes the study performs data organization and data analysis and prepares reports.
- Conducts and manages material compatibility studies for ASP sterilization and disinfection systems and consumable products.
- Supports to develop 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 and supports in new product development project through feasibility work to pilot production.
- Communicates effectively and comprehensively experiment status/testing results to others.
- Supports andcoordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.
- Supports OOS NC and CAPA investigations to higher level scientists as needed.
- Provides training to other laboratory personnel in execution of testing procedures.
- Responsible for communicating business related issues or opportunities to next management level.
- Performs other duties assigned as needed.
Other Duties:
- Provides support to other programs and project teams that require chemistry testand technical expertise.
- Supports team focused on identifying and implementing process level efficiencies.
- Contributes to building extra ordinary team environment.
- Meets and ensures adherence to compliance standards including monitoring and compliance with the relevant guidance documents such as the ones from 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 closely related field with more than 3 years of applicable experience or Masters Degree in Chemistry or closely related field with 0-3 years of applicable experience including:
- Experience in the Medical Device or other GxP-regulated industry.
- Hands-on experience in laboratory environment analytical chemistry and material compatibility.
Knowledge Skills Abilities Certifications/Licenses and Affiliations:
- Strong understanding of compliance with applicable laboratory and safety procedure is required.
- Knowledge of sterilization disinfection and cleaning technologies for reprocessing of medical devices is preferred.
- Knowledge and experience of formulation chemistry and design of experiment (DOE) is preferred.
- Excellent hands-on experience in the R&D chemistry laboratory is required.
- A strong knowledge of analytical chemistry techniques is required.
- Knowledge and experience of analytical method development validation and transfer is preferred.
- Professional experience in a GxP-regulated industry and understanding of QSR FDA and ISO guidelines is preferred.
- Experience in validation or qualifying instruments in the GxP-regulated industry is preferred.
- Knowledge of material characterization and evaluation is preferred.
- Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment.
- Working experience with detergents sterilants and disinfectants is preferred.
- The successful candidate must be self-driven have strong critical thinking and problem-solving skills and capable of working independently or in a team.
Responsibility for Others and Internal Interactions:
Works effectively with cross-functional teams
External Interactions:
Ability to elevate inquiries from customers of ASP government agencies or auditors when occurs per ASP standard operating procedures
Supports communication with external suppliers service providers and manufacturers.
Scheduled Work Hours
Shift Work
Standing: Up to 80%
Kneeling: 0-10%
Sitting: Up to 50%
Walking: Up to 80%
All employees have a duty to comply with applicable laws regulations standards ASP policies and procedures.
This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills efforts duties responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.
Employment Type
Full-Time
