{"id":1596413,"url":"https://alion.io/job/landauer-scientist-ii","title":"Scientist II","company":{"id":2079593,"name":"LANDAUER","domain":"landauer.com","url":"https://alion.io/company/landauer","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":81,"open_postings":21,"ghost_share":0,"stale_share":0.762,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-10T05:45:15Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":69000,"max_usd":143000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":542},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-21T21:15:52Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-11T17:43:24Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"The Scientist II, R&D Biochemistry and Microbiology (B&M), primarily supports projects for new product development (NPD), and assists life cycle management (LCM) activities, with sustaining product related projects for ASP products in alignment of company’s strategic plan under the leaderships of both R&D and Operations in close collaboration with the cross-functional manufacturing team.\nDuties and Responsibilities\nUnder supervision of manger or general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:\nSupport 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\nBiochemical and Microbiological activities include analyses of enzymes, liquid culture for BI production, and analytes from cultivation, production, and application of microorganisms\nAssist microbial fermentation development and commercialization\nSupport 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\nWork closely with manufacture engineers to integrate ASP product manufacturer process and systems\nDemonstrate 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\nSupport life cycle management activities for consumable medical device products as well as any associated NC or CAPA investigations \nProvide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology\nAssist of strategic vision or plan by collaborating with other cross functional departments \nCommunicate business related issues to management timely\nPerforms other duties assigned as needed\nBe responsible for communicating business related issues or opportunities to next management level \nPerforms other duties assigned as needed\nOther Duties\nExecute of product development and validation, in support of production commercialization for medical device reprocessing and infection control projects \nMeet 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 \nEducation\nMinimum 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\nMS degree in Microbiology or equivalence with 0 - 2 years of applicable experience\nYears of Related Experience:\nAt least 2 years of experience in the Medical Device or other GxP-regulated industry\nAt least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions\nAdditional experience and familiarity with IQ/OQ/PQ and PV processes and requirements preferred \nExperience in microbial fermentation preferred\nKnowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:\n(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)\nCapability 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). \nHands on testing experiences for Biological Indicator (BI) manufacturing (e.g., titers, D-value, stability testing) and sterilization (e.g., cycle validation) are preferred \nExperience 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\nCapability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, and quality engineering etc.) \nDemonstrated experience in process development and/or validation \nKnowledge of analytical techniques and experience with analytical method development, validation, and transfer\nThe successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a team \nMust possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment\nCompliance\nAll employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures.\nThis job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. 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