Job Description

This role supports the new Rapid Diagnostics Solutions (RDS) business unit in San Diego, California, part of the group of diagnostics businesses at Thermo Fisher Scientific. We are focused on increasing access to affordable innovations in diagnostic testing and enabling data-driven decisions. What we do matters because our work has a direct impact on people2019s lives, and we take that responsibility seriously.

Position Summary:

The Scientist I, Formulation is responsible for developing, optimizing, and manufacturing solutions and materials that will be utilized in assay components and subassemblies. This position will work closely with Manufacturing/Research Technicians and Engineers, and will participate in process improvements, cost optimization, quality testing, inventory management and labor accountability.

Key Responsibilities:

2022 Maintain and set-up documentation and control procedures that meet ISO 13485 and FDA requirements
2022 Fill out batch records and follow cGMP and GDP compliance 2022 Develop and optimize materials and methods that will be used in biochemistry formulations
2022 Use balances, pipetting equipment, spectrophotometric and pH instruments to make and test solutions for production and R&D activities
2022 Operate technical equipment in the manufacture of reagents, proteins, and subcomponents
2022 Work directly with QA personnel to ensure the components meet or exceed product specifications
2022 Develop SOPs, batch records, IQ/OQ/PQ, calibration, and preventative maintenance documents

Minimum Requirements/Qualifications:

2022 2-5 years of experience in an in-vitro diagnostic or CLIA laboratory setting
2022 Bachelor of Science or Bachelor of Arts degree, preferably in Biology or Chemistry or equivalent, is required

Personal attributes:

2022 Self-direct and stay on track with multiple concurrent assignments/projects, and assist in any area that helps Thermo Fisher Scientific achieve its goals and objectives
2022 Be able to work and manage lab inventory and storage processes
2022 Ability to trouble shoot simple process issues/problems and communicate with supervisors when they arise
2022 Strong organization, communication, and interpersonal skills
2022 Basic math and calculations skills, and ability to read, write and speak English
2022 Strong attention to detail
2022 Extensive experience with Microsoft Office

Non-Negotiable Hiring Criteria:

2022 Must have direct knowledge and/or experience of PCR, chemical conjugation, and formulation of IVD diagnostic products
2022 Direct knowledge of dilutions, metric units and analytical processes utilized in the manufacturing of enzyme solutions
2022 Thorough knowledge of cGMP and ISO 13485 requirements to ensure adherence to policies and regulations