Posted in Other 30+ days ago.
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Type: Full Time
Location: Gaithersburg, Maryland
As a member of the Lentigen Quality team, you will have the opportunity to lead in the development, implementation, and maintenance of the Site Microbial Contamination Control program for cell therapy products in a GMP environment. You will also provide QA oversight of the Environmental Monitoring program and Aseptic Processing Simulation activities, drive microbial contamination deviations and ensure that the proper CAPAs are effectively implemented. You will have the opportunity to oversee the cleaning and disinfectant qualification, cleaning validation program and drive risk management and change controls. You will work jointly with other units across the site to develop and maintain processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP for the Lentigen site's clinical and commercial pipelines. Additionally, you will be responsible for overseeing the validation program for QC Microbiology, as well as leading the implementation of the bioburden and endotoxin testing programs to support microbial control strategy. The unique duties of this position will consist of coordinating release for final cell-based therapeutic products for clinical applications. The role will interact with all site and cross-site functions that could impact Lentigen's microbial control program including Facilities, QC Microbiology, Manufacturing, Process Development. Overall, your leadership ability and deep knowledge of quality will champion the continued development of Miltenyi Biotec products and growing success.
* B.S. degree in Microbiology, or scientific discipline or equivalent
* Minimum of 5 years' progressive experience in Quality Control; or equivalent combination of education and experience.
* Experience in aseptic processing, cell therapy, and FDA inspections
* Strong knowledge of US and EU pharmaceutical GMPs
* Must be familiar with the implementation of microbiological environmental monitoring programs and must understand the interpretation of microbiological data including evaluation of trends.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have the ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.
Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.
At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as a core strength of our company. We are scientists, engineers, physicians, support specialists, and more - all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus, we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.
Lentigen Technology, Inc. is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity