Operations Manager, HPC

About Ossium

Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.

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.

We offer a full slate of employee benefits including:

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays

Employer paid life insurance and long term disability

Gym membership/recreational sports reimbursements

Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

If reasonable accommodation is needed, please contact our People Team at [email protected] or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.

Principals / direct applicants only please. Recruiters, please do not contact this job poster.

Equal Opportunity Employer/Veterans/Disabled