Director, Commercial Manufacturing

Role SummaryThe Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient‐specific therapies. This role drives consistent batch execution, operational discipline, and cross‐functional alignment to meet on‐time patient delivery while maintaining the highest standards of quality and safety.The Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP‐regulated environment.ResponsibilitiesCommercial Manufacturing OversightProvide strategic and day‐to‐day leadership for GMP manufacturing operationsEnsure consistent execution of manufacturing batches in alignment with production schedules and patient needsDrive right‐first‐time execution and minimize deviations, batch failures, and delaysEnsure rapid resolution of manufacturing issues with minimal impact to patientsPatient‐Centric Delivery ExecutionOwn manufacturing performance metrics tied to patient delivery:On‐time batch release and shipmentCycle time adherenceSchedule attainmentPartner cross‐functionally with Quality, Supply Chain, and Patient Operations to ensure seamless delivery of autologous therapiesQuality and ComplianceEnsure full compliance with cGMP, regulatory requirements, and internal quality systemsPartner closely with Quality Assurance to:Drive deviation reduction and investigation closureMaintain inspection readinessSupport audits and regulatory inspectionsPromote a strong quality culture and accountability at all levelsSafety LeadershipChampion a culture of safety across manufacturing operationsEnsure compliance with EHS requirements and proactively mitigate risksLead investigations and corrective actions for safety incidentsLean Manufacturing and Continuous ImprovementEstablish and sustain lean manufacturing systems, including:Visual managementStandard workTiered accountabilityDaily performance managementLead continuous improvement initiatives to enhance:ThroughputCapacity utilizationCost efficiencyProcess robustnessUtilize data‐driven decision‐making and performance dashboardsPeople Leadership and DevelopmentBuild, lead, and develop high‐performing teams across manufacturing and support functionsEstablish clear goals, performance expectations, and accountability structuresFoster a culture of engagement, ownership, and continuous learningQualifications & RequirementsProduction Associate Roles: must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color‐coded components in a GMP environment.Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video‐based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.Bachelor's degree in Life Sciences, Engineering, or related field (required)10+ years of experience in biopharmaceutical manufacturing, with a strong preference for cell or gene therapy5+ years in senior leadership roles managing GMP manufacturing teamsProven experience in autologous or patient‐specific manufacturing environmentsDemonstrated success in scaling manufacturing operations and improving execution performanceDeep knowledge of cGMP regulations and regulatory expectationsStrong background in lean manufacturing and operational excellence methodologiesAdvanced degree (MS, MBA, or PhD) preferredBenefitsThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job‐related factors as permitted by law. For remote‐based positions, this range may vary based on your local market. Full‐time employment positions will also be eligible to receive pre‐IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on‐site locations.