Technician I, Process Development

About the Role

BioSpace is seeking a Technician I, Process Development for their Boca Raton, Florida location. This role supports the development of new technologies through laboratory and pilot-scale experiments and is partially responsible for the optimization of manufacturing processes and implementation of regulatory requirements.

Key Responsibilities

• Conducts laboratory and pilot-scale experiments to support the development of new technologies.
• Partially responsible for the optimization of manufacturing processes and implementation of regulatory requirements.
• Assists in process development activities, creating 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, and interprets data to improve processes.
• Conducts lab-scale studies including processing of plasma proteins.
• Operates centrifuges, filtration apparatus, and chromatography systems.
• Routinely uses monitoring instruments such as pH/conductivity meters, spectrophotometer, and scale.
• Routinely performs sample and buffer preparation including labeling.
• Performs equipment and area cleaning.
• Completes documentation and data entry as required for procedures and tests performed.
• Adheres to Safety and cGMP practices.
• 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.
• Note: The standard schedule is 8:00 AM to 5:00 PM, but 12-hour rotating shifts may be required during operational campaigns and manufacturing model runs.

Requirements & Tech Stack

• Time management skills and ability to balance multiple job assignments.
• Strong organizational, critical thinking, reasoning, and problem-solving abilities.
• Strong interpersonal and collaborative skills.
• Familiarity with basic lab equipment: pH meter, spectrophotometer, scale, pipettes, pumps.
• Computer skills: MS Word, Excel, LIMS.
• Excellent organizational skills.
• Ability to interact effectively with internal and external colleagues and managers.
• Capacity to work at small scale and transfer to larger applications.

Qualifications

• Education: B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related scientific discipline.
• Experience: Up to two years of experience in a laboratory setting.
• Preferred Experience: Previous work experience in a regulated environment (FDA, EPA, etc.).
• Compliance: Strict adherence to FDA regulations and company policies, completion of required compliance training, accurate documentation, adherence to data privacy regulations, proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education on FDA regulations.