Scientist II

Duties And Responsibilities

Under supervision of manager or general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

• Support projects, activities, and applications related to principles of biochemistry and microbiology from R&D, operations, and QA with focuses on development and improvement of procedures for NPD and sustaining biological indicator (BI) production
• Biochemical and Microbiological activities include analyses of enzymes, liquid culture for BI production, and analytes from cultivation, production, and application of microorganisms
• Assist microbial fermentation development and commercialization
• Support 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
• Work closely with manufacture engineers to integrate ASP product manufacturer process and systems
• Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements
• Support life cycle management activities for consumable medical device products as well as any associated NC or CAPA investigations
• Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology
• Assist of strategic vision or plan by collaborating with other cross functional departments
• Communicate business related issues to management timely
• Be responsible for communicating business related issues or opportunities to next management level

Other Duties

• Execute of product development and validation, in support of production commercialization for medical device reprocessing and infection control projects
• Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance

Education

Minimum experience and education for this position is a bachelor's degree in a scientific discipline, such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field with 3 – 5 years of experience, or MS degree in Microbiology or equivalence with 0 – 2 years of applicable experience

Years Of Related Experience

• At least 2 years of experience in the Medical Device or other GxP-regulated industry
• At least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions
• Additional experience and familiarity with IQ/OQ/PQ and PV processes and requirements preferred
• Experience in microbial fermentation preferred

Knowledge, Skills, Abilities, Certifications/Licenses, And Affiliations

• Capability to execute study protocols, analyze data, and propose theoretical solutions/explanations for reprocessing and sterilization of medical devices or Biological Indicator manufacturing studies (e.g., D-value, stability testing)
• Hands on testing experiences for Biological Indicator (BI) manufacturing (e.g., titers, D-value, stability testing) and sterilization (e.g., cycle validation) are preferred
• Experience on company operation related with bacterial endospore production, Biological Indicator (BI) manufacturing, medical device reprocessing, and terminal sterilization as well as a thorough understanding of microbiology sterilization/disinfection principles are preferred
• Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, and quality engineering etc.)
• Demonstrated experience in process development and/or validation
• Knowledge of analytical techniques and experience with analytical method development, validation, and transfer
• The successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a team
• Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment