Staff Scientist

About the role

The Staff Scientist is responsible for R&D 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.

Responsibilities

• Lead liquid culture for microbial fermentation process development and implementation
• Collaborate on the studies for enzyme purification and activity control with biochemistry SME
• Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects
• Lead R&D and life cycle management activities; provide guidance to other scientists as needed
• Lead design changes for marketed products such as manufacturing steps, process, or design validations, product testing, marketing analysis ensuring robust processes that meet CTQs
• Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems
• Lead or support and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principals and procedures
• Support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology (e.g., biological indicator)
• Prepare and assist of strategic vision or plan by collaborating with other cross functional departments
• Communicate business related issues to management timely
• Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents from such as ISO, QSR or FDA, and in preparation of documentation demonstrating compliance

Requirements

• 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, and 7-9 years of applicable experience, or a master’s degree with 5-7 years of applicable experience, or a PhD with 2-4 years of applicable experience
• Related Experience: At least 7 years of experience in the Medical Device or other GxP-regulated industry preferred
• At least 5 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
• Knowledge and Skills: Fermentation on microbial liquid culture and its upstream and downstream process experience are strongly preferred; Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles 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.); Provide guidance and supervisory role to microbiology associates conducting hands-on testing for Biological Indicator manufacturing (e.g., titers, D-value, stability testing) or sterilization (e.g., D-value and cycle validation); Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred; 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

Qualifications

• Self-driven, innovative, strong critical thinking and problem-solving skills, capable of working independently or in a team
• Effective oral and written communication skills, capable of functioning in a cross-functional team environment
• Supervise or train junior scientists
• Collaborate with Quality Assurance, Supply Chain, and Regulatory Affairs partners

Benefits

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.

Pay

The salary range for this position (in local currency) is 131,215 - 219,075