Operations Manager, HPC

Operations Manager, HPCOssium'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.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 QualificationsBS/BA in a technical field or equivalent experience5+ years of manufacturing or related experience3+ years in a formal people-leadership roleWorking knowledge of aseptic technique, cleanroom operations, and cGTP/cGMP requirementsExperience owning deviations, investigations, and CAPAs, including root cause analysisExcellent written and oral communication skills, with the ability to present results to cross-functional stakeholdersHigh level of attention to detail and the ability to operate with organization and urgency in a dynamic environmentPreferred QualificationsAdvanced degree in a relevant scientific disciplineDirect experience managing teams in an aseptic manufacturing environmentTrained in statistical process control and continuous improvement tools and methodologiesExperience supporting FDA or other regulatory and accreditation inspectionsExperience with process validation and technology transfer from development into routine productionFamiliarity with lean or tiered daily management practicesKey ResponsibilitiesOwn daily HPC production output from donor intake through cryopreservation and initial inventory, ensuring every gift is used for its authorized purposeManage HPC Production Supervisors across shifts, ensuring processes are scheduled with appropriately trained and qualified personnelServe as operator, verifier, or trainer during clinical production as neededDevelop and report production metrics such as throughput, yield, right-first-time documentation, deviation rate, and cycle time, and drive action where targets are missedPerform technical review of production batch records and ensure traceability of donor products through final dispositionWrite and oversee event reports, investigations, risk assessments, and CAPAs, including effectiveness checksLead operational changes through project management, document creation, batch record revision, and risk assessmentServe as hiring manager for HPC production roles and oversee onboarding, qualification, and ongoing training for the teamServe 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 MSATAccountable for the Core Team balanced scorecard covering safety, quality, process control and capability, variability reduction, throughput, supply chain planning, productivity, training, and equipment reliabilityKeep the HPC process in control, capable, and compliant, prioritizing effectiveness before efficiency, and lead periodic formal process reviews and Annual Product Review feedbackEstablish the Core Team floor presence schedule and ensure development plans are in place for frontline supervisors and staffPartner with Tissue Production, MSAT, Engineering, Quality, Supply Chain, and Facilities on shared suites, materials, equipment, and process improvementsPhysical RequirementsMust be able to work in a moderately noisy environmentMust be able to work around biohazardous materials and chemicalsRequired 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 lbsMust 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 salariesStock options401(k) matchingMedical, dental and vision coverageFour weeks of PTO accrued (vacation & sick time) annually + 11 company holidaysEmployer paid life insurance and long term disabilityGym membership/recreational sports reimbursementsOssium 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 View email address on click.appcast.io or View phone number on click.appcast.io. 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