Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Loud Noises (Equipment/Machinery), 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

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that positively impacts a global scale. Join our colleagues in bringing our Mission to life daily to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, ensuring our food is safe, or helping find cures for cancer.

Location/Division Specific Information

Fremont, CA / Clinical Diagnostics Division

Discover Impactful Work:

You will contribute to manufacturing products for the Bulk Formulations TDM team and completing associated cGMP documentation. You will also work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvement projects.

A Day in the Life:

• 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 and analyze raw data for in-process adjustments and product release.

• Review other manufacturing operators/scientist’s batch records.

• Maintain and analyze 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 operational efficiencies and support business needs through 5s and lab clean-ups.

• Modify SOPs, work instructions, and reports with mentorship.

• Initiate and support investigations for quality documentation, including non-conformances, CAPAs, and Variances.

• Maintain and troubleshoot testing and formulation equipment as appropriate.

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

• Perform other job duties as needed.

Keys to Success:

Education

• BS/BA in a scientific field in Chemistry, Biochemistry, or related technical field preferred (equivalent combinations of education, training, and relevant work experience may be considered).

Experience

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

• IVD immunoassay manufacturing experience preferred.

Knowledge, Skills, Abilities

• 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.

• Must be organized and thorough, and can prioritize own and other’s work to meet business efficiency metrics.

• Self-sufficient, self-motivated, and focused.

• Ability to routinely lift 25 pounds.

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!

Compensation and Benefits

The salary range estimated for this position based in California is $63,800.00–$95,750.00.

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

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.