Job Abstract

Work Schedule

Environmental Conditions

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.

Fremont, CA / Clinical Diagnostics Division

How will you make an impact?

The formulations scientist will manufacture products for the bulk formulations team and complete associated cGMP documentation. You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects.

What will you do?

• Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP standards

• Perform in-process testing using clinical analyzers, review and analyze data

• Review other manufacturing operators/scientist’s batch records

• Maintain and analyzes lot histories for trends and discrepancies

• Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration

• Participate in process improvement projects to improve efficiencies and support business needs

• May modify SOPs, work instructions and reports with guidance

• Initiate and support investigations for nonconformances and deviations

• Maintain and troubleshoot equipment as appropriate

• Keep department supervisor and/or manager updated on all issues

• Perform other job duties as required

How will you get here?

• High shool diploma or equivalent required

• BS/BA in scientific field (Chemistry or Biochemistry preferred)

• Equivalent combination of education and years of related experience may be substituted

• 1+ years of related experience and/or training preferred

• IVD immunoassay manufacturing experience is preferred

• Experience in working with potentially hazardous chemicals and human source materials preferred

• Familiarity with Quality System Regulations and ISO 13485 regulations is a plus

• Strong laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions

• Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations

• Ability to be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics

• Self-sufficient, self-motivated, and focused

• Ability to routinely lift 25 pounds

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

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