Product Owner, SAP Manufacturing Systems at Cellares

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

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

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

Skills

SAP S/4HANA

SAP ECC

PP-PI

EWM

GMP

GxP

21 CFR Part 11

MES

Tulip

Werum PAS-X

LIMS

SAP ATTP

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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