Scientist I, Manufacturing Sciences

Thermo Fisher Scientific•Detroit, MI

5d•Onsite

About The Position

Discover Impactful Work: Aligns with our 4i values; integrity, Innovation, intensity, and involvement. Ensures global regulatory compliance and continuously improves the quality of our products & services. Location: On-site in Detroit, MI. 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 screening. A day in the Life: Performs hands-on laboratory and process activities using established procedures to support manufacturing, process understanding, and product readiness. Supports investigations and the implementation of Corrective and Preventive Actions (CAPA). Supports efforts to identify and reduce sources of process variability. Supports the design and execution of Design of Experiments (DOE) using the MSAT laboratory. Collects in-process samples from the manufacturing floor and conducts analysis using MSAT laboratory equipment to support product understanding, continuous improvement, and investigations. Supports the development and maintenance of operating procedures for analytical and pilot MSAT laboratory equipment. Records and analyzes batch records and in-process data to support process and product understanding. Supports manufacturing operations and reviews manufacturing data to identify opportunities to improve yield and reduce scrap. Supports the implementation of new products and processes. Utilizes Quality Management System (QMS) and other documentation systems with appropriate guidance. Accurately captures information and performs calculations within controlled documents and supports the preparation of batch records, summary reports, and Standard Operating Procedures (SOPs). Works effectively in both laboratory and manufacturing environments.

Requirements

BS or higher in biological engineering, chemical engineering, biomedical engineering or a related STEM field with 0-3 years of experience.
Experience with Standard Operating Procedures (SOPs), batch records, investigation practices and GMP in the biotechnology/pharmaceutical/chemical industry.
Running protocols in a laboratory environment.
Operating analytical chemical equipment such as HPLC and ICP.
Statistical/data analysis.
Process improvement/ process optimization
Process/ product Investigations
Manufacturing process and equipment knowledge.
Possess a good foundation in general scientific practices, principles, and concepts of your field.
Independent prioritization, ability to navigate shifting priority in support of operations.
Ability to wear Personal Protective Equipment (PPE).
Ability to lift up to 25 pounds repetitively, and up to 65 pounds non-repetitively.
Able to work critical and shifting timelines while demonstrating a ‘can do’ attitude.
Ability to work overtime and nonstandard work schedules as required to meet production schedule.
May handle biologic substances.

Responsibilities

Performs hands-on laboratory and process activities using established procedures to support manufacturing, process understanding, and product readiness.
Supports investigations and the implementation of Corrective and Preventive Actions (CAPA).
Supports efforts to identify and reduce sources of process variability.
Supports the design and execution of Design of Experiments (DOE) using the MSAT laboratory.
Collects in-process samples from the manufacturing floor and conducts analysis using MSAT laboratory equipment to support product understanding, continuous improvement, and investigations.
Supports the development and maintenance of operating procedures for analytical and pilot MSAT laboratory equipment.
Records and analyzes batch records and in-process data to support process and product understanding.
Supports manufacturing operations and reviews manufacturing data to identify opportunities to improve yield and reduce scrap.
Supports the implementation of new products and processes.
Utilizes Quality Management System (QMS) and other documentation systems with appropriate guidance.
Accurately captures information and performs calculations within controlled documents and supports the preparation of batch records, summary reports, and Standard Operating Procedures (SOPs).
Works effectively in both laboratory and manufacturing environments.