Responsibilities
- Lead and support SAP supply chain modules (MM, PP, WM, QM, and potentially ATTP or IBP) tailored to biotech/life sciences operations
- Lead the design and integration of SAP to support chain-of-identity (COI) and chain-of-custody (COC) for patient-specific products, from apheresis to administration
- Design, configure, and implement SAP solutions in alignment with GMP-compliant processes (e.g., batch management, serialization, lot traceability)
- Collaborate with cross-functional teams in Manufacturing, Quality, Regulatory, Procurement, and Logistics to gather requirements and translate them into SAP functionality
- Support validation efforts and ensure SAP system changes comply with 21 CFR Part 11, Annex 11, and other regulatory standards
- Develop and maintain functional specifications, SOPs, user training/work instruction materials, and test scripts (IQ/OQ/PQ)
- Troubleshoot and resolve SAP system issues related to material master data, BOMs, routing, batch records, MRP, and shop floor integration
- Participate in audits and inspections, providing documentation and system walkthroughs as required
- Work closely with IT, QA, and external partners to manage change control processes and ensure business continuity
- Support integration with MES, LIMS, WMS, or serialization systems
Requirements
- Bachelor’s degree in Supply Chain, Information Systems, Engineering, Life Sciences, or a related field
- 5+ years of SAP experience in a supply chain consulting or analyst role, preferably in a GMP-regulated environment
- Hands-on experience with SAP ECC or S/4HANA (MM, PP, WM, QM)
- Strong understanding of biotech/pharmaceutical manufacturing processes and GMP/CSV requirements
- Experience working in validated environments with GxP documentation practices
- Excellent problem-solving and communication skills with the ability to interface across all levels of the organization
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
- SAP S/4HANA implementation experience
- Knowledge of serialization (SAP ATTP), SAP IBP, or integration with MES or WMS platforms
- Familiarity with FDA, EMA, or ICH regulatory frameworks
- Experience with Agile or hybrid project methodologies
Top Skills
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
