Position Summary

The Technician I, Process Development, conducts laboratory and pilot-scale experiments that support the development of new technologies. Partially responsible for the optimization of manufacturing processes and implementation of regulatory requirements. Assists in process development activities, creates scalable processes with improved product yield and reduced manufacturing systems costs. Researches and assists with the implementation of new methods and technologies to enhance operations. Collects, analyzes, interprets and data to improve processes.

Essential Functions (ES) and Responsibilities

• The standard schedule for this position is 8:00 AM to 5:00 PM, but employees may frequently be required to work 12-hour rotating shifts during operational campaigns and manufacturing model runs.
• Conducts lab scale studies that include processing of plasma proteins.
• Conducts laboratory and pilot-scale experiments to evaluate and develop new technologies.
• Operation of centrifuges, filtration apparatus, and chromatography systems
• Routine use of monitoring instruments such as pH/ conductivity meters, spectrophotometer, and scale
• Routinely performs sample and buffer preparation including labeling.
• Equipment and Area cleaning 
• Completes  documentation and data entry as required for procedures and tests performed.
• Adheres to Safety and cGMP practices in execution of job functions.
• Performs testing as needed to generate data for validation and special projects.
• Fulfills requests from management for assistance in other matters as needed.
• Assists in creating scalable processes.
• Assists the manufacturing operations team in problem solving with regard to equipment and systems.
• Participates in the design and start-up of new manufacturing facilities and equipment.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Education Requirements: B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related scientific discipline required. 

• Experience Requirements: Requires up to two years of experience in a laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc) is preferred.  Must have the capacity to work at small scale and to transfer to larger applications. Must be familiar with basic lab equipment (pH meter, spectrophotometer, scale, pipettes, pumps, etc.) Requires  computer skills (MS Word, Excel, LIMS, etc). Requires excellent organizational skills, and the ability to interact effectively with internal and external colleagues and  managers.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.