The Project Manager will lead SAP implementation projects in GMP-regulated environments, overseeing project lifecycles, compliance, and cross-functional collaboration within biotech operations.
We are seeking a skilled Project Manager with strong experience in SAP implementation and support in GMP-regulated environments to lead cross-functional projects across our biotech operations.
The primary focus of this position will be to ensure the successful delivery of strategic initiatives involving ERP systems, supply chain, manufacturing, and compliance, while maintaining strict adherence to GxP and FDA regulations. This is a multidisciplinary role & this individual will further interface across many parts of the company to drive SAP implementation.
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
- 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
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.
Top Skills
Csv
Erp
Gmp
Manufacturing (Pp)
Quality Management (Qm)
Sap (Ecc Or S/4Hana)
Supply Chain (Mm
Wm)
Cellares South San Francisco, California, USA Office
345 Allerton Ave, South San Francisco, CA, United States, 94080
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