Responsibilities
- Lead cross-functional projects involving SAP (ECC or S/4HANA), particularly in Supply Chain, Manufacturing, Finance and Quality modules (e.g., MM, PP, QM, WM)
- Manage project lifecycle from initiation to closure, including planning, resourcing, budgeting, risk mitigation, and reporting
- Ensure all projects comply with GMP, CSV (Computer System Validation), and 21 CFR Part 11 regulations
- Coordinate with business and technical stakeholders to define requirements, scope, and deliverables
- Manage project documentation including project charters, timelines, test plans, validation protocols (IQ/OQ/PQ), and SOPs
- Serve as the liaison between IT, Quality, Regulatory, Manufacturing, and Supply Chain functions
- Track and report progress to stakeholders and executive leadership; escalate risks and issues as needed
- Support audits and inspections by providing relevant project documentation and participating in walkthroughs
Requirements
- Bachelor’s degree in Life Sciences, Information Technology, Engineering, Business, or related field
- 5–10 years of project management experience in the biotech, pharmaceutical, or life sciences industry
- Demonstrated experience leading SAP-related projects in GMP-regulated environments
- Solid understanding of ERP processes in manufacturing, quality, inventory, and supply chain
- Proven track record managing complex cross-functional teams and delivering projects on time and within scope
- Familiarity with CSV, GxP, data integrity, and regulated system documentation
- PMP, PRINCE2, or equivalent project management certification
- Experience with SAP S/4HANA
- Experience with Agile, hybrid, or GxP-compliant SDLC methodologies
- Exposure to integration with MES, LIMS, WMS, or serialization systems
- Excellent communication, leadership, and stakeholder management skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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.
