Manager, Manufacturing *PC 1430

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.

Manager, Manufacturing

Based On-site in Gaithersburg, MD

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.