Senior Manager, Quality Control (Microbiology) *PC 1426

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Your Tasks:

The role is responsible for managing operational activities and personnel within the QC department. The role may oversee activities such as in-process and final product release testing, stability testing, analytical testing of raw materials and/or microbiology samples, environmental monitoring, and other analytical testing in a GMP compliant environment. The role will also be responsible for collaborating with other operational groups to achieve successful completion of manufacturing, testing and release of cell therapy products.

Essential Duties and Responsibilities:

• Schedule management: Plan and execute on approved QC schedule and coordinate QC tasks with other departments and to be compliant with GMP requirements.
• Documentation: Review and provide oversight on QC records (may include Change Controls, CAPAs, Deviations, Lab Investigations, and Continuous Improvement) and other GMP documents.
• GMP Compliance: Champion and ensure that the site QC aligns and operate in accordance to Quality and GMP guidelines.
• Systems: Implement QC systems to ensure continue improved GMP compliance. This will involve developing, reviewing and revising SOPs, protocols and reports.
• Data Management & integrity: Review test data packets, provide technical guidance to QC analysts. This may involve managing non-conformance events and lead investigations.
• Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.

Requirements:

• Bachelor's degree in the life sciences or related concentration from a four-year college or university; Minimum of 8 years working related and progressive experience (either in microbiology/sterility control, release testing of cellular therapy or biological products) in a quality control setting and a minimum 3 years' progressive management experience including scheduling QC operations and working with multiple shift teams; or equivalent combination of education or experience.
• Experience in writing, reviewing, and implementing SOP's and quality systems (deviations, CAPAs, change controls) is essential.
• Experienced background with FDA, EMA, cGMP, GLP, and ICH guidelines related to CMC quality control
• Depending on the specific discipline of the role, detailed knowledge of the following:
  
  
  
  • molecular/cell biology techniques such as PCR, flow cytometry, tissue culture, ELISA
  • microbiological tests including rapid sterility; considerations for microbiological control of a GMP biological manufacturing plant
  • environmental monitoring and clean utilities
  • microbial or raw material compendial monographs
  • statistical software such as JMP for trend analysis and/or DOE
  • primer design and sequence analysis
  
  
  
  
• Strong leadership and management skills to grow Quality team.
• Proven ability to critically review and analyze data and proactively solve problems.
• Proven organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills are critical.
• Excellent interpersonal skills, organizational skills, written and oral communication skills.

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 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.

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, 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 cultured human cells (immortalized, not primary) and lentivirus-derived vector particles. 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.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.

Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.

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

Miltenyi Biotec, Inc. participates in E-Verify.