Sr. Scientist

Responsible for life cycle management (LCM) activities and projects pertaining to biological indicator (BI) products; lead new and sustaining product related projects for ASP products in support of the company’s strategic plan.Duties and ResponsibilitiesUnder general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:Lead life cycle management activities, provide guidance to other scientists as needed.Lead process changes for Biological Indicator production such as manufacturing steps, process, or equipment validations, product testing, ensuring robust processes that meet CTQs.Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems.Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects.Lead or support and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principles and procedures.Support biological indicator liquid culture development and implementation.Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology (e.g., biological indicator).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.Be responsible for communicating business related issues or opportunities to next management level.Perform other duties assigned as needed.QualificationsEducation: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 5 – 7 years of applicable experience, or a master’s degree with 3 – 5 years of applicable experience, or a PhD degree with 0 – 2 years of applicable experience.Years of Related Experience :At least 4 years of experience in the Medical Device or other GxP-regulated industry preferred.At least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred.Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements required.Professional experience and understanding of QSR, FDA, and ISO guidelines required.Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations :Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferred.Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred.Capability to develop study protocols, analyze data, and propose theoretical solutions/explanations for sterilization or biological indicator manufacturing studies (e.g., D-value, stability testing). Sound statistical analysis is required (i.e., Minitab, etc.).Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, quality engineering, etc.).Knowledge of AAMI/ISO standards in the area of biological indicators and/or terminal sterilization.Demonstrated experience in process development and/or validation preferred.Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferred.Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred.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.

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