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.

Senior Microbiologist

San Jose, CA

Your Tasks:

As a member of the Miltenyi Biotec team, you will lead in the development, implementation, and maintenance of the Site Microbial Contamination Control program for cell therapy products in a GMP environment. Additionally, you will oversee the validation program for QC Microbiology, as well as leading the implementation of the bioburden and endotoxin testing programs to support microbial control strategy. As a result of your leadership ability and deep knowledge of quality, you will support the continued success of Miltenyi Biotec as a whole.

Among other responsibilities, you will:

• Provide QA oversight of the Environmental Monitoring program and Aseptic Processing Simulation activities, drive microbial contamination deviations and ensure that the proper CAPAs are effectively implemented.
• Oversee the cleaning and disinfectant qualification, cleaning validation program and drive risk management and change controls.
• Develop and maintain processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP for the clinical and commercial pipelines.
• Coordinate release for final cell-based therapeutic products for clinical applications.
• Interact with all site and cross-site functions that could impact Miltenyi' s microbial control program including Facilities, QC Microbiology, Manufacturing, Process Development.

Requirements:

• B.S. degree in Microbiology, or scientific discipline or equivalent and a minimum of 5 years’ progressive experience in Quality Control; or equivalent combination of education and experience.
• Experience in aseptic processing, cell therapy, and FDA inspections.
• Strong knowledge of US and EU pharmaceutical GMPs.
• Must be familiar with the implementation of microbiological environmental monitoring programs and must understand the interpretation of microbiological data including evaluation of trends.

• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

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 25 pounds. 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.

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 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 expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Experience

• Minimum of 5 years’ progressive experience in Quality Control; or equivalent combination of education and experience

Education

• Bachelors or better in Life Sciences or related field

Behaviors

• Team Player: Works well as a member of a group
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well