Job Description:

Description

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.

Quality Control Manager, Validation

Gaithersburg, MD

Your Tasks

You will be responsible for the review and execution of Analytical Method Validation, including the monitoring of performance of validated methods, as well as overseeing the transfer of Qualified methods internally. Additionally, you will plann, design, and execute validation activities and oversee monitoring of validated methods and trending performance.

Among other responsibilities, you will:

• Perform oversight of transfer of qualified methods internally.


• May supervise of a team focused on validation and related activities


• Maintain close working relationship with Process Development and Assay Transfer Groups, and others.


• Manage documentation upkeep and creation; including methods and Validation Reports


• Train and mentor others as needed.

Requirements

• Bachelor's Degree in biological science or related disciplines required and a minimum of 5 years' related experience and/or training in a GMP environment including at least 3 years' relevant validation execution experience; or equivalent combination of education or experience.


• Extensive experience effectively supporting FDA inspections, EU regulators and supplier audits. Working knowledge of industry regulatory guidance.


• In-depth knowledge and full understanding of pharmaceutical GMPs (US and EU);


• Clear understanding of standards of practice used in the manufacture of biotechnology products


• Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines


• Hands on understanding of Biopharmaceutical Quality Control, proactive material management, effective and timely cross functional communication


• Strong knowledge of MS Office, including Access, Excel and Word. PowerPoint and Visio knowledge a plus.

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 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.

Work Environment

This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom 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.

Progress prospers with inspiration and curiosity. For 30 years Miltenyi Biotec has been developing products and services that are used in basic research, translational research and cell therapy. Today we are a team of more than 3,000 scientists, physicians, engineers, marketers and numerous other specialists.

At Miltenyi Biotec, innovative ideas are being turned into cutting edge products. Together, we are passionate about driving biomedical progress towards curing severe diseases.

Lentigen Technology, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity