Manager

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.

Summary:

This position is primarily responsible for managing cross-functional operational activities while ensuring production areas are inspection ready. This position is also responsible for assessing process capacity and planning requirements while driving continuous improvement.

Responsibilities include mentor Manufacturing (MFG) staff, provide an engaging working environment promoting the Miltenyi core values and competencies, be client facing, maintain and execute the manufacturing schedule and batch release schedule, manage Central Services, Materials Planning, Cell and Gene Therapy and/or Upstream and Downstream processes and teams, author and/or review and approve SOPs, batch records, and other controlled documents, collaborate with departments (QA, QC, MM, finance, IT, PD Facilities, Validation, MSAT).

Responsibilities:

• Manage and actively participate as needed in Drug Product and/or Drug Substance teams and manufacturing (MFG) processes.
  • Responsible for maintaining the assigned schedule.
  • Oversee cross-functional operations to assure timely delivery of goods within industry safety and GMP requirements.
  • Ensure Manufacturing production and QC Laboratory areas are inspection ready and 5S compliant.
• Trains and manages the performance of the MFG staff, ensures that department training (GMP, Safety, Corporate) is performed on time and documented.
• Monitors the maintenance of production equipment and areas for the GMP manufacturing suites.
• Develops/revises documentation, (i.e., batch records, SOPs and other documents) to support equipment/facility operation.
  • Initiate/manage Manufacturing change controls.
• Ensures adherence to schedules as provided by Department head. Schedules and communicates manufacturing operations within the facility.
  • Manages/Drives the batch release schedule.
  • Pro
  • actively assesses resource needs and leads efforts to reduce production costs and improve efficiencies.
• Manages department KPI and metric updates and drives lean six sigma projects.
  • Drive improvement ideas/opportunities within Manufacturing.
• Investigates all failures (equipment, process, product) and assists in determining root cause. Initiates/manages deviations and CAPAs.
  • Responsible for ensuring appropriate CAPA are identified and implemented.
  • Ensures timely completion and submission of all Manufacturing Investigation Reports and documentation of deviations to minimize production delays.
  • Works with QA and others to troubleshoot upstream and downstream production issues.
• Ensures safety and quality standards are always met or exceeded maintaining an inspection ready facility.
• Provide client facing information and issue updates in virtual and in-person meetings; provide tours and escort clients.

Requirements:

• Bachelor‘s degree - biological science or related disciplines
• At least 8 years of progressive experience in a cGMP biologics production facility for cellular therapy and/or large molecule biological products in a cGMP manufacturing environment or equivalent combination of education or experience.
• At least 4.5 years of progressive management or equivalent combination of education or experience.
  • Experience with direct processing and leading cell and gene therapy processes/production and/or mammalian cell culture and production of viral vaccines or viral vectors across multiple shift teams.

Knowledge:

• Highly Technical and Strong Process knowledge in field of Biopharmaceutical Manufacturing Vector processing and / or Cell and Gene therapy Manufacturing
• Knowledge in SAP or similar ERP system is a plus.
• Implementation and use of Single-use technology is desired.
• Familiarity with application of QbD, cGMP, EUA, ICH, FDA, PIC-S, PDA guidelines related to CMC MFG industry standards and regulations.

Skills:

• Strong leadership skills with a demonstrated ability to effectively collaborate with cross-functional and global multi-location teams.
• Proven ability to critically review and analyze data and proactively solve problems
• Solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills are critical.
• Ability to adapt in a fast-paced environment.
• Proven ability to motivate, mentor, coach and lead manufacturing staff and flexibility in managing operations.
• Must have excellent 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 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:

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.

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

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