Quality Control Assay Associate
QC Assay Associate
As a member of the Miltenyi Biotec Quality team, you will have the opportunity to participate in the daily Quality Control activities associated with biological and molecular assay processes. Additionally you will be involved with QC release testing and environmental monitoring to support the GMP manufacturing of T–Cells and CAR–T Cells. The unique duties of this position will consist of supporting the QC assay development process including the design, execution, and analysis of development studies and reports, the execution of QC release, in-process and stability testing of raw materials, intermediates and cell based final products. Furthermore, you will be responsible for writing, reviewing, and revising test methods, assay qualification protocols, SOPs, and other controlled documents. Overall, your technical nature will champion the continued development of Miltenyi Biotec products and growing success.
•B.S. degree in biological science or related discipline
•Minimum of 1-2 years’ experience with hands-on QC testing or analytical development preferably in a cellular manufacturing environment; or equivalent combination of education and experience
•Must possess a working knowledge of cGMP, GLP, and ICH guidelines
•Must have experience in molecular and cell biology techniques such as PCR/qPCR and flow cytometry
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.
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 medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, 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 such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.
Miltenyi Biotec is a company that 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 Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.
Miltenyi Biotec North America, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity