Biomanufacturing Technician - Central Services

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.

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.

Specific duties, activities, and responsibilities include:

• 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.
• Actively participates in the client Way (Continuous Improvement Culture).
• 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.

Education/Experience:

High School Diploma.

Behavioral Requirements:

Ability to see and hear and read and write clear English. Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary. Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time. Ability to cooperate with coworkers within an organized team environment or work alone. Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines. Ability to put aside personal opinions and focus on business needs, department needs or group needs.