Advanced Sterilization Products, Inc.
Staff Scientist, R&D Chemistry
Advanced Sterilization Products, Inc., Irvine, California, United States, 92713
The Staff Scientist, Chemistry, serves as an expert in technical areas, works under minimal supervision and uses knowledge of scientific techniques and process excellence to design and develop new cleaning and disinfection/sterilization products in compliance with new product development procedures, leads complex projects requiring cross-functional support and participation.Duties and Responsibilities
Under minimal supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:Leads, plans, and executes research projects in support of new technologies associated with cleaning and disinfection or sterilization of medical instruments.Demonstrates thorough knowledge of own technical area, and adequate knowledge of other areas impacted by own function.Designs and executes scientific experiments and protocols to support product development from initial feasibility to final product verification/validation.Presents data with appropriate analysis, and documents findings and conclusions in technical reports.Develops, validates, and transfers test methods in support of product commercialization for medical device reprocessing and infection control projects.Collaborates with Marketing, Quality, Supply Chain, and Regulatory partners to design, develop, and commercialize new products; represents R&D in cross-functional teams.Provides support and advice to other programs and project teams requiring chemistry expertise.Supports lifecycle management activities for our capital and consumable medical device products as well as any associated NC or CAPA investigations.Manages laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports.Ensures quality of projects including design, execution, data summary and interpretation, and report preparation/review, adherence to GDP and applicable regulations.Understands and adheres to compliance standards including monitoring, compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance.Provides instructions or supervision to lower-level scientists and professionals; manages routine processes and sets of tasks.Works independently to plan, conduct, and manage multiple research projects to meet department and company objectives.Independently determines and develops approaches to solutions with technical guidance on the most unusual or complex problems.Performs and/or coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.Maintains awareness of the advances and needs in cleaning, sterilization/disinfection of medical instruments.Stays current on the latest applicable laboratory techniques, advances, and technology.Develops new ideas and applications through journals, patents, scientific reviews, and technical meetings.Communicates business-related issues or opportunities to management.Performs other duties assigned as needed.Other Duties:
Leads on identifying and implementing process level efficiencies.Supports design changes for marketed products such as manufacturing steps, process or design validations, product testing, marketing analysis ensuring robust processes at suppliers that meet CTQ’s.Provides initial and final review of data generated by peers and contract laboratories.Participates in technical group discussion/process improvement workshop(s) and solves complex problems.Contributes to building an extraordinary team environment.Qualifications/Education:
Bachelor’s Degree, Master’s Degree or Ph.D. in Chemistry or closely related field.Years of Related Experience:
A Bachelor’s Degree in Chemistry or closely related field with 10+ years of applicable experience, Master’s Degree in Chemistry or closely related field with 7+ years of applicable experience, or Ph.D. in Chemistry or closely related field with minimum 3 years of applicable experience.Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
Strong understanding of compliance with applicable laboratory and safety procedure is required.Knowledge in organic chemistry and formulated products is required.Experience with solid phase chemistry and packaging is preferred.Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing of medical devices is preferred.A strong knowledge of analytical chemistry techniques is required; knowledge of analytical method development, validation, and transfer is required. The test methods include but not limited to HPLC, UV-VIS, titrations, and wet chemistry test methods and USP methodology.Professional experience in a GxP-regulated industry and understanding of FDA, ICH, and ISO guidelines is required. Understanding of the requirements for medical device/regulated consumable products launching are required.Professional experience in the medical device industry and experience with new product development, scale up, technology transfer, process validation is required.Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment.Strong track record of scientific publications and/or patents is preferred.Experience of providing instruction to professional and technical employees on projects and initiatives is required.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.Leads core team and represents R&D on cross-functional teams.Provides instructions or supervision to lower-level scientists and professionals.Coordinates and reviews the work of others.Assists and provides instruction to laboratory colleagues in solving complex problems.External Interactions:
Ability to elevate inquiries from customers of ASP, government agencies or auditors, when occurs, per ASP standard operating procedures.Leads communication with external suppliers, service providers, and manufacturers.Collaborates with external laboratories to form study plans, execute the studies, and analyze the results.Supports VOC (voice of customers) collection and translates VOC to generate product concept.Physical & Work Environment Requirements
Physical Requirements:
The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear.Work Environment:
Travel on the Job:
10-20% Domestic, InternationalScheduled Work Hours:Shift Work:
NoOn Call (Call in for Work):
NoApproximate Position Requirements:Standing:
Up to 40%Kneeling:
0-10%Sitting:
Up to 60%Walking:
Up to 40%Additional Work Environment Requirements:
NoneThe salary range for this position is $99,700.00 - $185,000.00. ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology. ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
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Under minimal supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:Leads, plans, and executes research projects in support of new technologies associated with cleaning and disinfection or sterilization of medical instruments.Demonstrates thorough knowledge of own technical area, and adequate knowledge of other areas impacted by own function.Designs and executes scientific experiments and protocols to support product development from initial feasibility to final product verification/validation.Presents data with appropriate analysis, and documents findings and conclusions in technical reports.Develops, validates, and transfers test methods in support of product commercialization for medical device reprocessing and infection control projects.Collaborates with Marketing, Quality, Supply Chain, and Regulatory partners to design, develop, and commercialize new products; represents R&D in cross-functional teams.Provides support and advice to other programs and project teams requiring chemistry expertise.Supports lifecycle management activities for our capital and consumable medical device products as well as any associated NC or CAPA investigations.Manages laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports.Ensures quality of projects including design, execution, data summary and interpretation, and report preparation/review, adherence to GDP and applicable regulations.Understands and adheres to compliance standards including monitoring, compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance.Provides instructions or supervision to lower-level scientists and professionals; manages routine processes and sets of tasks.Works independently to plan, conduct, and manage multiple research projects to meet department and company objectives.Independently determines and develops approaches to solutions with technical guidance on the most unusual or complex problems.Performs and/or coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.Maintains awareness of the advances and needs in cleaning, sterilization/disinfection of medical instruments.Stays current on the latest applicable laboratory techniques, advances, and technology.Develops new ideas and applications through journals, patents, scientific reviews, and technical meetings.Communicates business-related issues or opportunities to management.Performs other duties assigned as needed.Other Duties:
Leads on identifying and implementing process level efficiencies.Supports design changes for marketed products such as manufacturing steps, process or design validations, product testing, marketing analysis ensuring robust processes at suppliers that meet CTQ’s.Provides initial and final review of data generated by peers and contract laboratories.Participates in technical group discussion/process improvement workshop(s) and solves complex problems.Contributes to building an extraordinary team environment.Qualifications/Education:
Bachelor’s Degree, Master’s Degree or Ph.D. in Chemistry or closely related field.Years of Related Experience:
A Bachelor’s Degree in Chemistry or closely related field with 10+ years of applicable experience, Master’s Degree in Chemistry or closely related field with 7+ years of applicable experience, or Ph.D. in Chemistry or closely related field with minimum 3 years of applicable experience.Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
Strong understanding of compliance with applicable laboratory and safety procedure is required.Knowledge in organic chemistry and formulated products is required.Experience with solid phase chemistry and packaging is preferred.Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing of medical devices is preferred.A strong knowledge of analytical chemistry techniques is required; knowledge of analytical method development, validation, and transfer is required. The test methods include but not limited to HPLC, UV-VIS, titrations, and wet chemistry test methods and USP methodology.Professional experience in a GxP-regulated industry and understanding of FDA, ICH, and ISO guidelines is required. Understanding of the requirements for medical device/regulated consumable products launching are required.Professional experience in the medical device industry and experience with new product development, scale up, technology transfer, process validation is required.Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment.Strong track record of scientific publications and/or patents is preferred.Experience of providing instruction to professional and technical employees on projects and initiatives is required.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.Leads core team and represents R&D on cross-functional teams.Provides instructions or supervision to lower-level scientists and professionals.Coordinates and reviews the work of others.Assists and provides instruction to laboratory colleagues in solving complex problems.External Interactions:
Ability to elevate inquiries from customers of ASP, government agencies or auditors, when occurs, per ASP standard operating procedures.Leads communication with external suppliers, service providers, and manufacturers.Collaborates with external laboratories to form study plans, execute the studies, and analyze the results.Supports VOC (voice of customers) collection and translates VOC to generate product concept.Physical & Work Environment Requirements
Physical Requirements:
The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear.Work Environment:
Travel on the Job:
10-20% Domestic, InternationalScheduled Work Hours:Shift Work:
NoOn Call (Call in for Work):
NoApproximate Position Requirements:Standing:
Up to 40%Kneeling:
0-10%Sitting:
Up to 60%Walking:
Up to 40%Additional Work Environment Requirements:
NoneThe salary range for this position is $99,700.00 - $185,000.00. ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology. ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
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