Posted in Other 30+ days ago.
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Type: Full Time
Location: Gaithersburg, Maryland
As a member of the Lentigen Technology Manufacturing team, you will have the exciting opportunity to investigate and document manufacturing-related quality events. In addition, you will use your subject matter expertise in biologics manufacturing and Quality systems to participate in internal and external audits. Furthermore, you will contribute to the development, writing, and review of SOPs, SMPs, BPRs, and other GMP documentation. The unique duties of this position will allow you to provide technical expertise and interact as part of a collaborative team environment. Overall your exceptional ability to be the subject matter expert and work on projects of a diverse nature will propel the continued growth and success of Lentigen Technology.
* You hold a B.S. in the life sciences
* Minimum of 5 years of experience in a GMP manufacturing and/or Quality systems environment.
* You are detail-oriented and can be the subject matter expert for GMP manufacturing.
* You have a thorough understanding of Quality Systems in support of GMP operations.
* You are an effective communicator (both verbal and written)
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. 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 works around standard medical and research equipment. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses, and gloves. 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