Biomanufacturing Technician, Central Services
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Overview
Job Description
ONSITE POSITION - SHIFT - WED - SAT 10PM - 8AM.I. Department Overview:The Manufacturing department is responsible for the execution of clinical and commercial manufacturing inaccordance with regulatory, site, and client requirements. Manufacturing cGMP production activities includesolution 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 istasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and wastereduction 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 skillsand training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufactureof biopharmaceutical products within a clean room environment. The position is expected to follow detailedinstructions 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 rightfirst-time execution.
" documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, andother quality documentation.
" recognizes deviations from the intended procedure and raises awareness through the Rapid Responseprocess.
" 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 tobring 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.Education/Experience:Central Services
" High School Diploma.ehavioral 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 anaccurate, timely, safe, and professional manner with supervisor, group members, and other departments asnecessary.
" Ability to manage time effectively to complete assignments in expected time frame and independentlyseek 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 multipledeadlines.
" Ability to put aside personal opinions and focus on business needs, department needs or group needs.
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