Operations Manager, HPC

About the Job

The Operations Manager, HPC leads the hematopoietic progenitor cell (HPC) production team that turns organ donor vertebral bodies into bone marrow and other cell therapy products. You will own the HPC value stream at our Indianapolis facility, from donor intake and allocation to cell processing and cryopreservation, and the supervisors and operators who run it across shifts. You will also lead the cross-functional Core Team that ensures reliable production of HPC, Marrow and work closely with Tissue Production, MSAT, Engineering, Quality, and Supply Chain. This is a hands-on leadership role in a cleanroom environment: you will spend real time on the floor, and you will also own the metrics, the investigations, and the plan for scaling the team.

Required Qualifications

• BS/BA in a technical field or equivalent experience
• 5+ years of manufacturing or related experience
• 3+ years in a formal people-leadership role
• Working knowledge of aseptic technique, cleanroom operations, and cGTP/cGMP requirements
• Experience owning deviations, investigations, and CAPAs, including root cause analysis
• Excellent written and oral communication skills, with the ability to present results to cross-functional stakeholders
• High level of attention to detail and the ability to operate with organization and urgency in a dynamic environment

Preferred Qualifications

• Advanced degree in a relevant scientific discipline
• Direct experience managing teams in an aseptic manufacturing environment
• Trained in statistical process control and continuous improvement tools and methodologies
• Experience supporting FDA or other regulatory and accreditation inspections
• Experience with process validation and technology transfer from development into routine production
• Familiarity with lean or tiered daily management practices

Key Responsibilities

• Own daily HPC production output from donor intake through cryopreservation and initial inventory, ensuring every gift is used for its authorized purpose
• Manage HPC Production Supervisors across shifts, ensuring processes are scheduled with appropriately trained and qualified personnel
• Serve as operator, verifier, or trainer during clinical production as needed
• Develop and report production metrics such as throughput, yield, right-first-time documentation, deviation rate, and cycle time, and drive action where targets are missed
• Perform technical review of production batch records and ensure traceability of donor products through final disposition
• Write and oversee event reports, investigations, risk assessments, and CAPAs, including effectiveness checks
• Lead operational changes through project management, document creation, batch record revision, and risk assessment
• Serve as hiring manager for HPC production roles and oversee onboarding, qualification, and ongoing training for the team
• Serve as Core Team Leader for HPC, Marrow: own the Core Team charter, lead the daily meeting, set the agenda for weekly meetings, and drive cross-functional alignment across Production, Quality, Engineering, and MSAT
• Accountable for the Core Team balanced scorecard covering safety, quality, process control and capability, variability reduction, throughput, supply chain planning, productivity, training, and equipment reliability
• Keep the HPC process in control, capable, and compliant, prioritizing effectiveness before efficiency, and lead periodic formal process reviews and Annual Product Review feedback
• Establish the Core Team floor presence schedule and ensure development plans are in place for frontline supervisors and staff
• Partner with Tissue Production, MSAT, Engineering, Quality, Supply Chain, and Facilities on shared suites, materials, equipment, and process improvements

Physical Requirements

• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Required to work the majority of the shift aseptically in a controlled environment with limited breaks. This environment requires special gowning (ie. over the head, face, hands, feet and body).
• Must be able to lift, push, pull and/or carry up to 50 lbs
• Must have sufficient manual dexterity, hand/finger coordination, wrist mobility, wrist stability, and grip strength to handle, feel, grasp, manipulate, and operate objects, manual and power tools, equipment, and controls safely and accurately.
• Regularly required to sit, stand, walk, squat, balance, climb, stoop, kneel, crouch and reach with arms.