Operations Manager, HPC

Ossium Health•Indianapolis, IN

4d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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