Scientist III, Particles manufacturing Full-time

Scientist III – Particles Manufacturing

M-F 8-5, Onsite Freemont, CA – Kato Rd Facility

Compensation range depending on experience – $105,000 – $115,000

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.

Position Summary:

This position is responsible for manufacturing of particles products and completes associated documentation adhered to standard operating procedures (SOP) and current good manufacturing practices (cGMP) with the highest level of quality and compliance in a safe and timely manner that will meet customer expectations. Works with team members and biologicals to manufacture or qualify material for IVD use. Participates and/or lead in process improvement projects.

Key Responsibilities:

• Manufacture particle products, starting materials, and particle seeds strictly following cGMPs.
• Perform analytical and functional testing of particle products and raw materials.
• Provide leadership to successfully implement continuous improvement in quality, manufacturing cycle time, and total cost using the PPI Business System.
• Represent the Particles group in cross-functional meetings and support material qualifications.
• Update documents via MasterControl change control and Oracle ECO process.
• Lead and complete process validation as needed.
• Initiate, evaluate, and support investigations for non-conformances, CAPAs, and variances.
• Weigh, transfer, and mix required chemicals.
• Review and approve batch records and manage materials in ERP QAD.
• Lead 6S and participate in Kaizen and other process improvement efforts.
• Maintain and order lab supplies as needed.
• Train other chemists on equipment and procedures.
• Write, review, or modify SOPs, work instructions, and reports.
• Maintain, troubleshoot, and validate equipment as appropriate.
• Performs other job duties as required to meet business needs.

Minimum Requirements/Qualifications:

• B.S. or equivalent experience in Chemistry, Industrial Engineering, or related scientific/technical field.
• Minimum of 5 years of industry-related experience in a particles manufacturing environment.
• Proven expertise in diagnostic manufacturing with knowledge of laboratory and potentially hazardous chemicals.
• Advanced understanding of quality standards and regulatory compliance for medical devices or diagnostics.
• Strong technical skills in FDA, GMP, ISO 13485 compliance, process improvement, and development.
• Outstanding supply chain optimization expertise and project management experience.
• Practical experience with IT systems (ERP, MES, WMS, etc.).
• Excellent communication, executive presentation, and leadership skills.
• Outstanding organizational skills with the ability to multi-task.
• Ability to lead, motivate, and influence others.
• Must be able to lift 25 lbs routinely and up to 50 lbs occasionally.

At Thermo Fisher Scientific, your story matters. Join our collaborative team today and contribute to our world-class mission. Apply now!

Compensation and Benefits

The salary range estimated for this position based in California is $90,900.00–$116,000.00. 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.