• Job Description

  Req#: TFSCGLOBALR01219983EXTERNALENGLOBAL

  Job Description

  As we continue to grow at Thermo Fisher, we are seeking a Scientist III, Raw Material. Organizes and leads moderate to complex projects primarily focused on the validation of new raw materials (chemicals and biologicals) that are used in the manufacture of Thermo Fisher products. The Scientist III will provide direct technical support to the material validations by conducting analytical testing and analysis that includes but is not limited to raw material feasibility assessments, raw material quality investigations and manufacturing process troubleshooting. They will help identify raw material characteristics that are critical to assay performance and may work directly with suppliers to help develop and implement specifications to ensure product quality.

  Location/Division Specific Information

  Fremont, CA/Clinical Diagnostics Division

  How will you will make an impact?

  The Scientist III will work both independently and as a team member to conduct raw material Qualifications and manufactured product root-cause investigations. Define and develop test designs for raw material to evaluate the magnitude of the failure on product performance and assess residual product risk. They will analyze data and author writing raw material qualification plan, performing plans and qualification reports which will include a recommendation for the fitness of these raw materials for use in Thermo Fisher products.

  What will you do?

  • Plan, execute and document feasibility trials for new raw materials and/or manufacturing materials from current and alternate vendors.
  • Lead / Manage raw material qualification/ process improvement projects independently
  • Create and/or updates existing risk assessments based on new/alternate raw material risk assessment (e.g. FMEA).
  • Write validation plans, execute plans and writes validation reports.
  • Make pilots as part of raw material qualifications and test for performance testing and other Analytical testing as required for raw material validation projects and quality investigations.
  • Effectively communicate results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
  • Perform other work-related duties as assigned.

  How will you get here?

  Education

  • Bachelor’s degree in scientific field
  • Bachelors degree in Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred

  Experience

  • 1-3 years of experience working in a regulated environment
  • 3+ years of related experience preferred
  • Experience with automated Immunoassay clinical analyzers preferred
  • Experience with raw material qualifications preferred
  • Validation experience required, including authoring plans, reports and analyzing data using Minitab or equivalent statistical software
  • Demonstrated experience conducting root cause investigations, Process Excellence or equivalent methodologies
  • Experience performing and managing raw material qualifications testing

  Knowledge, Skills, Abilities

  • Strong organizational and leadership skills with the ability to multi-task and manage multiple projects
  • Effective communication and presentation skills
  • Flexibility in schedule based on business need
  • Adhering to all quality, regulatory and safety guidelines
  • Staying current with individual and company training plan
  • Accountable for clear and accurate documentation within Thermo Fisher quality system

  This position has not been approved for relocation assistance.

  Benefits

  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  Compensation and Benefits

  The salary range estimated for this position based in California is –.

  This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

  For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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