We are seeking a strategic and technically strong Product Owner, SAP Manufacturing Systems for Cell Therapy & GMP Compliance.
The primary focus of this position will be to lead the design, implementation, and optimization of SAP solutions tailored to cell and gene therapy operations. This role requires deep expertise in GMP-compliant manufacturing, SAP S/4HANA or ECC, and the complex workflows associated with personalized therapies such as autologous and allogeneic cell treatments. You will serve as a cross-functional leader and trusted advisor in aligning SAP with clinical and commercial cell therapy supply chains, ensuring full regulatory compliance, end-to-end visibility, and patient-centric operational excellence.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
Serve as the SAP solution architect for cell therapy manufacturing processes across SAP modules (PP-PI, QM, MM, WM/EWM), ensuring compliance with GMP/GxP and 21 CFR Part 11
Oversee SAP configuration and development efforts, ensuring scalability and traceability for both clinical and commercial advanced therapies
Collaborate closely with Manufacturing, Quality, IT, Regulatory, and Clinical Operations to define business requirements and translate them into validated SAP functionality
Drive integration with adjacent systems such as MES (e.g., Tulip, Werum PAS-X), LIMS, serialization platforms (SAP ATTP), patient scheduling, and cold chain logistics
Provide leadership for system validation, audit readiness, SOP development, and change management in alignment with GMP and global regulatory frameworks (FDA, EMA, ICH)
Act as SME in internal audits, regulatory inspections, and quality system assessments for digital manufacturing systems
Support continuous improvement initiatives within the digital supply chain and IT/OT domains
Requirements
Bachelor’s or Master’s degree in Engineering, Life Sciences, Information Systems, or related field
8+ years of hands-on experience with SAP in life sciences, including 5+ years focused on manufacturing or supply chain in GMP-regulated environments
Proven expertise in SAP PP-PI, QM, MM, and integration with production execution and serialization systems
Deep understanding of cell therapy manufacturing operations, including autologous/allogeneic workflows, scheduling, and chain-of-identity controls
Experience working in validated environments under GAMP5, Annex 11, 21 CFR Part 11, and data integrity expectations
Demonstrated success in system design and delivery for personalized or batch-level therapies
Experience with SAP S/4HANA, including advanced planning (PP-DS), ATTP, or EWM
Familiarity with cell therapy scheduling platforms, clinical supply chain integration, or patient engagement platforms
Experience in greenfield SAP implementations or digital transformation initiatives in biopharma
SAP certification is a plus
Experience with Agile or hybrid project methodologies
Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
