HPC Operations Lead, Cleanroom Cell Therapy

Elevate Ventures, Inc.; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

PTO + holidays

Life insurance

Gym membership

Job summary

Ossium Health is seeking an Operations Manager, HPC in Indianapolis to lead the hematopoietic progenitor cell production team. You will own the HPC value stream from donor intake to cryopreservation, manage supervisors across shifts, and partner with Quality, MSAT, and Engineering to ensure reliable production.

This hands-on leadership role requires extensive aseptic manufacturing experience, strong communication skills, and the ability to drive improvements while meeting regulatory standards.

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.

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

Skills

Leadership

Communication

Attention to detail

Aseptic technique

Organizational skills

Education

BS/BA in a technical field

Job description

Ossium Health is seeking an Operations Manager, HPC in Indianapolis to lead the hematopoietic progenitor cell production team. You will own the HPC value stream from donor intake to cryopreservation, manage supervisors across shifts, and partner with Quality, MSAT, and Engineering to ensure reliable production.

This hands-on leadership role requires extensive aseptic manufacturing experience, strong communication skills, and the ability to drive improvements while meeting regulatory standards.