Scientist III, Particles Manufacturing at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Fremont, California, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

115000.0

Posted On

19 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Chemistry, Industrial Engineering, Diagnostic Manufacturing, Quality Standards, Regulatory Compliance, Process Improvement, Project Management, Supply Chain Optimization, FDA Compliance, GMP Compliance, ISO 13485, Analytical Testing, Leadership, Documentation, Equipment Maintenance, Training

Industry

Biotechnology Research

Description

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description Scientist III, Particles Manufacturing M-F 8-5, Onsite Fremont, CA - Kato Rd Facility Compensation budget is depending on experience $90,900 to $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. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com. Location/Division-Specific Information: Fremont, CA. Relocation assistance is NOT provided. *Must be legally authorized to work in the United States without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screen. Discover Impactful Work: 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. A Day in the Life: 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. Keys to Success: Education and Experience B.S. or equivalent experience in Chemistry, Industrial Engineering, or related scientific/technical field required. 5+ years of industry-related experience in a particles manufacturing environment (equivalent combinations of education and relevant work experience may be considered). 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. 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 $90,900.00–$136,350.00. 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

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Responsibilities

This position is responsible for the manufacturing of particle products and completing associated documentation adhering to standard operating procedures and current good manufacturing practices. The role involves working with team members to manufacture or qualify material for IVD use and participating in process improvement projects.