Senior Scientist, R&D Chemistry

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.