The Senior Scientist, R&D Chemistry, works under limited supervision and uses knowledge of scientific techniques to design and develop new cleaning and disinfection/sterilization products in compliance to new product development procedures, supports complex projects requiring cross-functional collaborations.
Duties and Responsibilities
Under limited supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
- Plans and executes research projects in support of new technologies associated with cleaning and disinfection or sterilization of medical instruments.
- Demonstrates detailed knowledge of own technical area, and moderate knowledge of other areas impacted by own function.
- Prepares and executes protocols/studies to support product development from initial feasibility to final product verification/validation.
- Manages laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports.
- Conducts qualitative and quantitative chemistry analysis and performs data organization and data analysis and prepares technical presentation and technical reports.
- Analyzes experimental results, document findings, and prepare clear technical summaries that meet scientific, quality, and regulatory expectations.
- Supports development, optimization, and validation of laboratory methods, equipment, and processes to ensure reliability, compliance, and continuous improvement.
- Provides technical support to other programs and project teams requiring chemistry expertise.
- Assists in investigations related to nonconformances, test method issues, or quality events by performing data analysis, root cause assessments, and contributing to corrective actions.
- Provides training to lower-level scientists and manages routine processes and sets of tasks.
- 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.
- Develops solutions to problems of moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate action.
- Works independently to plan, conduct, and manage multiple research projects to meet department and company objectives.
- Seeks out new ideas and applications through journals, patents, scientific reviews, and technical meetings.
- Communicates business related issues or opportunities to next management level.
- 10% - 20% travel domestically or internationally
- Performs other duties assigned as needed.
Other Duties:
- May coordinate and review the work of others.
- Supports team focused on identifying and implementing process level efficiencies.
- Supports in maintaining awareness of the advances and needs in sterilization/disinfection, material compatibility, and biocompatibility.
- 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.
- Contributes to building extra ordinary team environment.
Qualifications
Education:
Minimum of a Bachelor's Degree in Chemistry or related field with 5+ years of applicable experience, or
Master's Degree in Chemistry or related field with 3+ years of applicable experience, or
Ph.D. in Chemistry or related field with 0-2 years of applicable experience including:
- Experience in the Medical Device or other GxP-regulated industry.
- Hands-on experience in laboratory environment, analytical chemistry and/or formulation chemistry.
- Experience in leading R&D Chemistry project, ability to independently execute and improve scientific work.
Knowledge, Skills, Abilities
- Strong understanding of compliance with applicable laboratory and safety procedure is required.
- Knowledge in organic chemistry and formulation development or surfactants, detergents, disinfectants, and sterilants 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 preferred.
- Strong track record of scientific publications and/or patents is preferred.
- Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines 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.
- Experience of providing instruction to professional and technical employees on projects and initiatives 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.
- Provides instructions or supervision to lower-level scientists and professionals.
- May coordinate and review the work of others.
- Assists 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.
- Supports VOC (voice of customers) collection and translate VOC to product concept generation.
- Supports communication with external suppliers, service providers, and manufacturers.
Bonus or EquityThis position is also eligible for bonus as part of the total compensation package.
Pay RangeThe salary range for this position (in local currency) is 101,200 - 169,050
