Project Manager, SAP GMP at Cellares

South San Francisco, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotech, Pharmaceutical, Life SciencesIndustries

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

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

Skills

SAP ECC

SAP S/4HANA

SAP MM

SAP PP

SAP QM

SAP WM

GMP

CSV

21 CFR Part 11

Project Management

ERP

Supply Chain

Manufacturing

Computer System Validation

IQ/OQ/PQ

Cellares

Develops and manufactures cell therapies efficiently

About Cellares

Cellares develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO). Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity and reduces costs and process failures compared to traditional methods. The company serves a range of clients, including pharmaceutical companies, and aims to provide efficient and cost-effective manufacturing services for cell therapies. Cellares stands out by combining development and manufacturing processes under one roof, making it a competitive option in the industry.

South San Francisco, CaliforniaHeadquarters

2019Year Founded

$345.3MTotal Funding

SERIES_CCompany Stage

Industrial & Manufacturing, BiotechnologyIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Stock Options

Risks

Emerging biotech startups threaten Cellares' market share with similar solutions.

Potential regulatory delays could impact scaling of new automated systems like Cell Q.

Supply chain vulnerabilities may disrupt production timelines for Cell Shuttle and Cell Q.

Differentiation

Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.

The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.

Cell Q automates QC processes, addressing bottlenecks in cell therapy quality control.

Upsides

Partnership with Sony enhances precision in cell therapy manufacturing processes.

Strategic partnership with Bristol Myers Squibb provides financial boost and validation.

Ossama Eissa's appointment as COO accelerates global expansion and operational capabilities.

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