BioFire Diagnostics
As part of the Analytical Production Securitization Industrialization team in the Engineering and Industrialization department, the Associate Process Scientist will perform projects to support the manufacturing of BACT/ALERT® Culture Media products. The position will primarily operate as project lead on multiple projects that will ensure cost savings and raw material securitization initiatives. This position directly impacts delivering lower cost BACT/ALERT product by lowering upstream raw material costs while ensuring supply chain continuity and supporting Quality Control and Operations functions to manufacture quality product.
Primary Duties
1. Analyses chemical and/or biologically derived raw materials for secondary/alternate sourcing projects for site securitization and/or cost savings initiatives.
2. Executes hands on laboratory testing at the bench scale, within final product, and through large scale validation activities.
3. Management of multiple projects will be required, wherein assessments are generated to assess interim progress and effectiveness.
5. Executes project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross‑functionally.
6. Perform all work in compliance with company quality procedures and standards.
7. Performs other duties as assigned.
Education, Skills and Experience
B.S. in Biochemistry or closely related field required with 2 years of experience in a regulated industry required
Or in lieu of a Bachelor's degree, 6 years of experience in a regulated industry, will be accepted.
M.S. in Biochemistry or closely related field preferred
Engineering/science role within medial device/diagnostic or pharmaceutical preferred
Project Management experience preferred.
Experience working in a cGMP environment preferred.FDA regulated cGMP industry experience preferred.
Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time.
Troubleshooting issues to identify and resolve problems efficiently
Solution oriented in the face of conflict
Drive for Results: Drive for Results while successfully removing barriers
Ability to work cross‑functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
Written Communications - including the ability to communicate technical data in written form
Working Conditions and Physical Requirements
Ability to remain in stationary position, often standing, for prolonged periods.
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
Ability to adjust or move objects up to 50 pounds in all directions.
Domestic travel required 10% of the time
International travel required 5% of the time
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Primary Duties
1. Analyses chemical and/or biologically derived raw materials for secondary/alternate sourcing projects for site securitization and/or cost savings initiatives.
2. Executes hands on laboratory testing at the bench scale, within final product, and through large scale validation activities.
3. Management of multiple projects will be required, wherein assessments are generated to assess interim progress and effectiveness.
5. Executes project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross‑functionally.
6. Perform all work in compliance with company quality procedures and standards.
7. Performs other duties as assigned.
Education, Skills and Experience
B.S. in Biochemistry or closely related field required with 2 years of experience in a regulated industry required
Or in lieu of a Bachelor's degree, 6 years of experience in a regulated industry, will be accepted.
M.S. in Biochemistry or closely related field preferred
Engineering/science role within medial device/diagnostic or pharmaceutical preferred
Project Management experience preferred.
Experience working in a cGMP environment preferred.FDA regulated cGMP industry experience preferred.
Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time.
Troubleshooting issues to identify and resolve problems efficiently
Solution oriented in the face of conflict
Drive for Results: Drive for Results while successfully removing barriers
Ability to work cross‑functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
Written Communications - including the ability to communicate technical data in written form
Working Conditions and Physical Requirements
Ability to remain in stationary position, often standing, for prolonged periods.
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
Ability to adjust or move objects up to 50 pounds in all directions.
Domestic travel required 10% of the time
International travel required 5% of the time
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