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 Analyst (Cell Factory)

Gaithersburg, MD

Your Tasks:

As a member of the Miltenyi team, you will have the exciting opportunity to support a team of cell therapy QC Analysts. You will primarily be responsible for day-to-day Quality Control activities which may include but is not limited to GMP activities, Assay Development, or supporting client and/or internal company projects while following applicable SOPs. You will apply your exceptional expertise and analytical testing skills to accomplish department objectives.

Essential Duties and Responsibilities:

• Work as part of a team to foster a culture of continuous improvement and operational excellence.

• Perform timely completion of QC test methods: flow cytometry analysis, nucleic acid extraction, qPCR, visual inspection under supervision.
• Generate SOPs for equipment and procedures used in routine biologics testing.
• Execute testing and resource schedule against operational plan. Support the on-time in full delivery of clinical & commercial material as required.
• Ensure performance of all process steps specific to the phase or stage of operation.
• Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements.

• Review of completed quality control documentation per compliance standards and established timelines.
• Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.
• Continuously seeking and supporting new approaches, practices, and processes to improve the efficiency and efficacy of quality control operations.

Requirements:

• Bachelor’s degree in biology, Biochemistry, Bioengineering, or related technical field with 2+ years of experience in quality control in biotech/pharma industry; or a combination of education and experience.

• Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
• Ability to deal with ambiguity, ready to change gears and plans quickly.
• Excellent interpersonal skills to successfully communicate with multi-disciplinary teams.
• Strong documentation, organizational, and writing skills enabling capability to provide summaries and reports
• Highly motivated, fast learner, detail-oriented team player. Good organization, initiative, and a collaborative attitude are essential.
• 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 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 clean 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 exposed to viruses and bacteria. Employees entering 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.

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.

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.

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