Responsibilities include but are not limited to:
• Thorough knowledge and understanding of upstream and downstream manufacturing process operations.
• Cell splitting and amplification within shake flasks, and bioreactors.
• Implement and initiate, CA/PA to satisfy GMP process deviations.
• Identification of CFR compliance gaps and recommend executable remediation plan.
• To ensure all activities meet the requirements of FDA, DEA, OSHA and EPA.
• Writing revising, and editing SOP's for the manufacturing process and facility
• Maintenance and organization of supply inventory.
• Interfacing, scheduling and on-site monitoring of any outside services of all manufacturing equipment
• Accurately document all manufacturing and/or service activities.
• Maintaining the cleanliness and organization of all manufacturing facilities.
• BS in chemistry, biology, microbiology, or chemical engineering
• 2-4 years of experience
• Experience with shake flask amplification, Wave disposable bioreactors, stir tank bioreactors and initiation of deviations, investigations
• Implementation of CA/PAs is expected of qualified candidate.
• GMP experience is mandatory
• Must be detail oriented, have strong written and oral communication skills.