Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
Fremont, CA/Clinical Diagnostics Division

Discover Impactful Work
As we continue to grow as 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 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, completing plans and qualification reports which will include a recommendation for the fitness of these raw materials for use in Thermo Fisher products.

A day in the Life
• Plans, complete and documents feasibility trials for new raw materials and/or manufacturing materials from current and alternate vendors.
• Leads / Manage raw material qualification/ process improvement projects independently
• Creates and/or updates existing risk assessments based on new/alternate raw material risk assessment (e.g. FMEA).
• Writes validation plans, implement plans and writes validation reports.
• Makes 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.
• Being able to analyze large sets of data for identifying trends using statistical tools like JMP or Minitab or any other statistical tools
• Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
• Performs other work-related duties including product support activities such trouble shooting product issues, CAPA/NCAR investigation, revising documents through MOC and ECO process etc.

Keys to Success

Education
• Bachelor’s degree in chemistry, Biology, Biotechnology, Chemical Engineering or related scientific field

Experience
• 3+ years of related experience required
• 2-3 years of experience working in a regulated environment preferred
• Experience with automated Immunoassay clinical analyzers preferred
• Experience with raw material qualifications preferred

Knowledge, Skills, Abilities
• 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.
• 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
• Hands on experience on automated clinical chemistry systems is a plus
Physical Requirements / Work Environment
The work is performed in an indoor office and lab setting.

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 $90,900.00–$136,000.00.

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