Scientist Ii

The Scientist II will report directly to the Staff Scientist or Stability Supervisor and will perform routine and complex testing in compliance with laboratory test methods and procedures to support the stability program, complaint testing, methods transfer and/or methods validation (80-100%). The Scientist II will receive general instructions about required tasks and results expected. Work will be well defined and will be reviewed for accuracy upon completion. The Scientist II is expected to apply standard practices and techniques in specific situations and to recognize discrepancies in results and follow operations through a series of detailed steps and processes. Additionally, the Scientist II has accountability and ownership to maintain the laboratory and laboratory instruments in their qualified state. The Scientist II will coordinate and ensure stability testing at specific intervals are assigned and complete appropriately.

Responsibilities:

Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures, and guidelines, this position:

• Understand and troubleshoot laboratory instruments and equipment.
• Perform daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment according to current SOPs.
• Working in compliance with current GMPs with regard to documenting, testing and maintaining accurate Laboratory notebooks and data sheets.
• Stability testing of finished goods and complaint analysis is part of this position. Coordination of stability sample pull points, review of stability data, labelling samples, and ensuring timely testing of identified in stability protocols.
• Initiation and participation in laboratory investigations of non-conforming laboratory test results.
• Work within a LIMS environment to document test results.
• Collecting and preparing laboratory records for evaluation following good documentation practices.
• Ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Complete initial review of data generated by peers and contract laboratories.
• Train or provide assistance in training Scientist 1.
• Coordinate the scheduling of stability and complaint testing.
• Responsible for communicating business related issues or opportunities to next management level.

Our Needs:

• Bachelor's Degree in a Scientific field, such as Chemistry, Biochemistry, Microbiology or Biology.
• A minimum of 2-5 years’ experience in the Pharmaceutical, Medical Device industry or other related field.
• Good Verbal and written communication skills.
• Presentation skills and use of Power Point.
• Ability to communicate in a cross-cultural environment.
• Fluent in MS Word and Excel.
• Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and knowledge of both regulatory requirements and other compliance areas.
• Ability to use Laboratory Software Applications such as Chromatographic Data Systems, Laboratory Execution Systems and Laboratory Information Management Systems.
• Ability to work independently and interact well with peers and colleagues.
• Understand dilutions, sterilization, work with analytical instruments (GC, HPLC, etc) or Microbial ID.

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 design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. 

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. 

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. 

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating. 

Fortive: For you, for us, for growth. 

Ready to move your career forward? Find out more at careers.fortive.com.

We Are an Equal Opportunity Employer

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 process should ask to speak with a Human Resources representative to request an accommodation.

Irvine, CA: The salary range for this position is $72,450 - $134,550

This position is also eligible for bonus as part of the total compensation package.

Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.