Senior Scientist, R&D Chemistry

Job description

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.