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Director of Operations - GMP Manufacturing at Miltenyi Biotec Inc

Posted in Other 30+ days ago.

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Type: Full Time
Location: Sunnyvale, California

Job Description:


Your Tasks
As a leader of the Miltenyi Operations Team, you will strategically direct clinical and preclinical operations to ensure the process is on time, on budget, and executed with high quality. You will apply your proven expertise to lead and translate cGMP regulations into operational tasks to ensure regulatory compliance and effective workflows. Including developing and implementing Critical Control Parameters for biological operational processes and strategies to maintain their control. Furthermore, you will work collaboratively with other key departments in the organization, consistently presenting data trends and results to create appropriate actions as needed. You will develop budgets, ensure that they are being adhered to, perform budget follow-up for pertinent stakeholders and recommend actions in an effort to achieve expected results. Last but not least, your responsibilities will include overseeing the Operations group to ensure high quality standards are maintained and will set expectations on project team performance, which will drive the continuing business success of Miltenyi Biotec as a whole.

* M.S. or B.S. in biology, chemistry, or related life sciences discipline and a minimum of 5 years' progressive GMP manufacturing/operational experience, preferably in cell therapy; or equivalent combination of education and experience
* Must have a minimum of 5 years management experience in a GMP regulated setting.
* Experience with in-depth understanding of primary cell processing and culture, closed system processing methods, and current GMP and GTP regulations in T-Cell or CAR-T Cells production preferred.

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 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, or crawl. 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 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, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

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