Sr. Scientist
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
15-10-2025
Vacancies:
1 Vacancy
Job Summary
Highly skilled and experienced Sr. Scientist to oversee and manage the day-to-day operations activities of Biological Indicators (BI) production lab. The successful candidate will be responsible for leading activities related to spore culture production ensuring the highest standards of quality and efficiency. This role requires a strong background in microbiology experience in spore culture techniques and the ability to manage teams activities and projects in a fast-paced production environment.
Duties and Responsibilities
- Lead day-to-day activities of the BI production lab including resource planning Daily Management ensuring smooth workflow and adherence to production schedules and meeting KPI targets
- Develop improve and implement standard operating procedures (SOPs) for spore culture production and related activities.
- Mentor and train laboratory Scientists and Biotechnicians providing guidance and support in their daily tasks.
- Lead process changes for Biological Indicator production such as manufacturing steps process or equipment validations product testing ensuring robust processes that meet CTQs
- Monitor and maintain laboratory equipment to ensure optimal performance and compliance with safety and regulatory standards.
- Work closely with manufacturing engineers to integrate biological indicator manufacturing equipment processes and systems
- Manage laboratory studies projects and processes/initiatives as well as initiates and completes technical reports
- Lead and document technical investigations NCs or CAPAs associated with biological indicator or other consumable processes systems or products according to GMP principals and procedures
- Demonstrate proficiency in applying established tools and methods (for example Six Sigma Lean) to identify and lead process and business improvement activities
- Be responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed
- Prepare and assist of strategic vision or plan by collaborating with other cross functional departments
- Represent production lab in Kaizens workshops PSP and other problem solving and improvement 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
Qualifications
Education
Minimum experience and education for this position is a bachelors 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 masters 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 preferred
- Professional experience and understanding of QSR FDA and ISO guidelines preferred
Knowledge Skills Abilities Certifications/Licenses and Affiliations:
- Proven experience in leading and managing laboratory activities teams and projects
- 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. stability testing). Sounds 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 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
Responsibility for Others and Internal Interactions
- This person may supervise or train junior scientists and lab technicians
- Collaborate with Quality Assurance Supply Chain and Regulatory Affairs partner
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Fortive Corporation Overview Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product d ... View more
