Scientist - MSAT Analytics
As a member of the Miltenyi Biotec Process Sciences team, you will have the exciting opportunity to lead the analytical transfer used in the testing of cellular therapy products into Process Sciences (PS) and into/out of Quality Control (QC). The duties of this position will consist of liaising between PS and QC while supporting the execution of studies in a laboratory setting. In addition, you will participate in research and development activities including reviewing, approving and authoring GMP documentation, protocols and reports. Furthermore, you will troubleshoot analytical issues, including investigations for root cause and implementation of corrective and preventive action plans. Overall, your expert technical understanding of analytical transfer will champion the continued development of Miltenyi Biotec products and growing success.
• Bachelor’s degree in a biological or biomedical discipline
• Minimum of 2 years’ progressive experience with clinical processing analytical testing in the cell therapy industry and/or cell culture operations in the biotechnology industry; or equivalent combination of education and experience
• Advanced understanding of relevant cell therapy characterization analytical methods, such as flow cytometry, ELISA and qPCR.
• Exposure to one or more advanced potency methods, such as cytotoxicity or cytokine characterization.
• Must have an advanced understanding cGMP and regulations/guidance and can interpret guidance documents and make technical recommendations.
• Must have an advanced understanding in statistical methods applicable to analytical transfer and qualification.
• Strong technical writing and communication skills.
• Advanced understanding of analytical transfer, qualification, and validation.
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. 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 50 pounds (dual lift). 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. Must be able to travel routinely by car and plane.
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.
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 Silicon Valley 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, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity