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Job DescriptionThe Therapeutic Production Chemist I/II/III will perform routine oligonucleotide manufacturing processes in the LGC Petaluma Therapeutic GMP suite. Critical analysis and understanding of oligonucleotide manufacturing activities.
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Job Description The Oligonucleotide Production Technician I – Synthesis will perform tasks associated with the production of modified oligonucleotides in a high throughput, fast paced, and time sensitive manufacturing environment.
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The Oligonucleotide Production Technician I will perform tasks associated with the production of modified oligonucleotides in a high throughput time sensitive manufacturing environment in compliance with company procedures and external regulatory requirements.
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Manufacturing Supervisor - Night Shift (18:00 - 07:00) Thursday - Saturday and every other Wednesday KEY RESPONSIBILITIES Leadership. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement o f our drugs to patients.
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Under direction of the Associate Director, GMP Maintenance and Calibration, the Instrumentation Supervisor will be responsible for leading a team of individuals in the calibration of instruments in the cGXP environment, including Facilities, Quality Control, Validation, and Manufacturing Departments.
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Additionally, the Supervisor will oversee complete documentation of all required calibration activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies and safety practices.
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Manufacturing operations are 24/7, so this requires multiple off shift coverage. Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations.
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The Therapeutic Production Chemist I/II/III will perform routine oligonucleotide manufacturing processes in the LGC Petaluma Therapeutic GMP suite. Perform manufacturing processes (synthesis, purification, desalt, freeze drying, etc) in accordance with the production schedule and maintain a high quality of work that aligns with internal standard operating procedures and cGMP protocols.
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This role is a Monday through Friday (5 day x 8 hrs) swing shift supporting the hours of 1300-2130. The Quality Control Analyst is responsible for performing microbiological/analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics.
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Experience in poultry processing/manufacturing environment preferred. Experience in poultry processing/manufacturing environment preferred. Occasional exposure to carbon dioxide vapors 10ppm and chlorine less than 20 ppm.
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