Assay Transfer & Qualification Scientist

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Your Tasks:
As a member of the Quality team, you will have the opportunity to drive Quality Control activities associated with biological and molecular assay transfer and qualification. You will further develop assays using ICH guidelines as your standards. You will assist the assay transfer from Process Development to GMP and will have a active role in assay qualification including report generation.  Assay development tasks will include identifying appropriate controls, standards and criteria for a valid assay, while qualification tasks will include writing, executing, and reporting qualification activities. Experience with sequencing analysis, primer design, reference sequence generation is preferred.  Overall, your exceptional skills, assay knowledge, and understanding of quality control will directly bring about the success of Lentigen Technology and Miltenyi Biotec as a whole.

Requirements:
• M.S. or PhD in the life sciences or a similar area of study and two to five years of related experience and/or training in biological and molecular assay methodology; or equivalent combination of education and experience.
• Experience with, but not limited to, PCR/qPCR, ELISA, restriction digests, cell based assays, flow cytometry, primer design, sequencing analysis.
• Strong knowledge of quality compliance (GMP, ICH, FDA, EP, and USP policies/guidelines).
• Thorough understanding of analytical bio-assays, including assay transfer qualification, validation, maintenance, and statistics.  Experience with Master Control and JMP preferred.
• Must be authorized to work in the U.S.

Physical Demands:
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 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
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 clean laboratory setting and routinely uses standard equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, 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 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 EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity