Director, Analytical Development
Director, Analytical Development
As a leader on the Miltenyi Biotec Process Development team, you will have the exciting opportunity to oversee the Analytical Development activities for the scalable production of cellular therapeutics (e.g., CAR – T Cells, gene-modified HSC, etc.) capable of supporting clinical trials and ultimate commercialization. The unique duties of this position will consist of analytical development planning and organization, designing and developing analytical suites for clinical use, developing and revising SOPs for analytical methods, overseeing the transfer and improvement of assay methods, maintaining and encouraging the standards of a cGMP facility, communicating with customers, and scheduling daily activities. Furthermore, you will be responsible for summarizing and presenting cell processing data for potential publication to internal and external audiences. Overall, your exceptional ability to supervise the activities and progress of our process development personnel will champion Miltenyi Biotec’s continued and growing success.
• Ph.D. in a life sciences or related discipline with 5 - 8 years’ experience in Analytical Development; or equivalent combination of education and experience
• Knowledgeable in Flow Cytometry including immunofluorescent staining for characterization of mixed blood cell populations, cytotoxicity and proliferation assays; as well as Human T cell subsets and characterization including activation, differentiation and exhaustion
• Experience in a cGMP and GLP environment with related regulatory guidance
• Previous experience working with human blood and tissue
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 50 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 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 such as scrubs, coveralls, masks, 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, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity