Manufacturing Technician

The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

II. Specific Duties, Activities, and Responsibilities:

This position is an entry-level position in the Manufacturing team and is the starting point to acquiring the skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.

The Technician…
• accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on “right-first-time” execution.
• documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation.
• recognizes deviations from the intended procedure and raises awareness through the Rapid Response process.
• proactively identifies safety, quality, and efficiency improvements.
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• may lead “Just Do It” (JDI) Continuous Improvement activities and implement CI projects.
• may coach more junior team members on basic execution activities and act as an “onboarding buddy” to bring new team members up to speed on culture and basic workplace expectations.
• participates in daily shift huddles and may lead shift exchange activities.
• performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards.
• completes all training activities required to maintain quality compliance within expected milestones.

Biomanufacturing – Central Services
• performs basic buffer preparation activities, including weighing raw materials for production.