Scientist III, Particles manufacturing at Thermo Fisher Scientific

Fremont, California, United States

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$105,000 – $115,000Compensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, DiagnosticsIndustries

Requirements

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

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

Skills

Key technologies and capabilities for this role

cGMPGMPSOPParticle ManufacturingAnalytical TestingFunctional TestingProcess ImprovementIVDPPE

Questions & Answers

Common questions about this position

What is the salary range for the Scientist III position?

The compensation range is $105,000 - $115,000 depending on experience.

Is this role remote or onsite, and where is it located?

This is an onsite position at the Kato Rd Facility in Fremont, CA, with a Monday-Friday 8-5 schedule.

What are the minimum qualifications for this role?

A B.S. or equivalent experience in Chemistry, Industrial Chemistry, or a related field is required.

What does the work environment involve for this position?

The role is in a laboratory setting with first shift days, requiring ability to lift 40 lbs., adherence to GMP safety standards, work in cold rooms/freezers, use of PPE, and handling hazardous/toxic materials.

What experience or skills make a strong candidate for this role?

Strong candidates have a B.S. in Chemistry or related field, experience following cGMPs in manufacturing particle products, performing analytical testing, leading process improvements, and handling documentation like SOPs and batch records.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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