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Manufacturing Technician
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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.