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 neededLead process changes for Biological Indicator production such as manufacturing steps, process, or equipment validations, product testing, ensuring robust processes that meet CTQsWork closely with manufacturing engineers to integrate biological indicator manufacturing processes and systemsExecute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projectsLead 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 proceduresSupport biological indicator liquid culture development and implementationProvide 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 improvementsBe responsible for communicating business related issues or opportunities to next management levelPerforms other duties assigned as neededQualificationsEducation: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 preferredAt least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferredAdditional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements requiredProfessional experience and understanding of QSR, FDA, and ISO guidelines requiredKnowledge, 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 preferredExperience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferredCapability 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 sterilizationDemonstrated experience in process development and/or validation preferredKnowledge of analytical techniques and experience with analytical method development, validation, and transfer preferredGreen Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferredThe successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a teamMust 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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