Scientist I, Manufacturing Sciences

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.

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.

Keys to Success

Education

• BS or higher in biological engineering, chemical engineering, biomedical engineering or a related STEM field with 0-3 years of experience.

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

Knowledge, Skills, Abilities

• 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.

Physical Requirements / Work Environment

• Frequently work at laboratory workstation and spend up to 40% of time on manufacturing floor.
• 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.
• Working conditions/physical requirements may change as required.