Operations Manager, HPC

<div class="content-intro"><h3><strong>About Ossium</strong></h3> <p>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.</p></div><h1><span style="font-family: helvetica, arial, sans-serif;"><strong>About the Job</strong></span></h1> <p><span style="font-family: helvetica, arial, sans-serif;">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.</span></p> <h2><span style="font-family: helvetica, arial, sans-serif;"><strong>Required

Qualifications</strong></span></h2> <ul> <li><span style="font-family: helvetica, arial, sans-serif;">BS/BA in a technical field or equivalent experience</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">5+ years of manufacturing or related experience</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">3+ years in a formal people-leadership role</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Working knowledge of aseptic technique, cleanroom operations, and cGTP/cGMP

requirements</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Experience owning deviations, investigations, and CAPAs, including root cause analysis</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Excellent written and oral communication skills, with the ability to present results to cross-functional stakeholders</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">High level of attention to detail and the ability to operate with organization and urgency in a dynamic environment</span></li> </ul> <h3><span style="font-family: helvetica, arial, sans-serif;"><strong>Preferred

Qualifications</strong></span></h3> <ul> <li><span style="font-family: helvetica, arial, sans-serif;">Advanced degree in a relevant scientific discipline</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Direct experience managing teams in an aseptic manufacturing environment</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Trained in statistical process control and continuous improvement tools and methodologies</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Experience supporting FDA or other regulatory and accreditation inspections</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Experience with process validation and technology transfer from development into routine production</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Familiarity with lean or tiered daily management practices</span></li> </ul> <h2><span style="font-family: helvetica, arial, sans-serif;"><strong>Key

Responsibilities</strong></span></h2> <ul> <li><span style="font-family: helvetica, arial, sans-serif;">Own daily HPC production output from donor intake through cryopreservation and initial inventory, ensuring every gift is used for its authorized purpose</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Manage HPC Production Supervisors across shifts, ensuring processes are scheduled with appropriately trained and qualified personnel</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Serve as operator, verifier, or trainer during clinical production as needed</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">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</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Perform technical review of production batch records and ensure traceability of donor products through final disposition</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Write and oversee event reports, investigations, risk assessments, and CAPAs, including effectiveness checks</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Lead operational changes through project management, document creation, batch record revision, and risk assessment</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Serve as hiring manager for HPC production roles and oversee onboarding, qualification, and ongoing training for

the team</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">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</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">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</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Keep the HPC process in control, capable, and compliant, prioritizing effectiveness before efficiency, and lead periodic formal process reviews and Annual Product Review feedback</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Establish the Core Team floor presence schedule and ensure development plans are in place for frontline supervisors and staff</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Partner with Tissue Production, MSAT, Engineering, Quality, Supply Chain, and Facilities on shared suites, materials, equipment, and process improvements</span></li> </ul> <h2><span style="font-family: helvetica, arial, sans-serif;"><strong>Physical

Requirements</strong></span></h2> <ul> <li><span style="font-family: helvetica, arial, sans-serif;">Must be able to work in a moderately noisy environment</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Must be able to work around biohazardous materials and chemicals</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">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).</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Must be able to lift, push, pull and/or carry up to 50 lbs</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">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.</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Regularly required to sit, stand, walk, squat, balance, climb, stoop, kneel, crouch and reach with arms.</span></li> </ul> <hr> <p><span style="font-family: helvetica, arial, sans-serif;"><strong>We offer a full slate of employee

benefits including:</strong></span></p> <ul> <li><span style="font-family: helvetica, arial, sans-serif;">Competitive salaries</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Stock options</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">401(k) matching</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Medical, dental and vision coverage</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Employer paid life insurance and long term disability</span></li> <li><span style="font-family: helvetica, arial, sans-serif;">Gym membership/recreational sports reimbursements</span></li> </ul><div class="content-conclusion"><div>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 <a href="https://ossiumhealth.com/wp-content/uploads/2025/05/Ossium-Health-2024-Equal-Employment-Opportunity-Policy-Statement.pdf" target="_blank">Equal Employment Opportunity Policy Statement</a> and the <a href="https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf" target="_blank">Know Your Rights: Workplace Discrimination is Illegal Poster</a> reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.</div> <div> </div> <div>If reasonable accommodation is needed, please contact our People Team at <a href="mailto:[email protected]">[email protected]</a> or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.</div> <div> </div> <div>Principals / direct applicants only please. Recruiters, please do not contact this job poster. </div> <div> </div> <div>Equal Opportunity Employer/Veterans/Disabled</div> <div> </div> <div> </div></div>