James S. Tutunjian
Branchburg Township
Summary
Dedicated executive with 25+ years of experience leading operations, supply chain, facilities, and project management, particularly within FDA-regulated production environments. Proven success in driving inclusive organizational development, cultural transformation, and high-performance teams. Demonstrated ability to design and implement strategic vision, improve operational quality (Right to Operate), increase profitability, and consistently reduce operating costs (including COGS reduction of over 50% in five years). Experienced in corporate acquisitions and integrations. Specialties: Operational Development, Agile Manufacturing, Regulatory Compliance, Strategic Planning, Cultural Advancement, Supply Chain Management, Project Management, Change Management, Facility Design and Setup, Automation Strategy
Overview
37
37
years of professional experience
Work History
Vice President, Operations
Roche Diagnostics
Branchburg
10.2024 - Current
- Executive leader responsible for Operations' manufacturing and support functions located at Branchburg New Jersey, and Carlsbad California (GenMark) manufacturing sites with oversight of over 1,000 employees.
- Oversee all operations activities, including the execution of manufacturing, logistics, planning, production controls, and manufacturing-related engineering for Roche Diagnostics product portfolios.
- Accountable for defining the global operations and manufacturing strategy to ensure achievement of financial and strategic goals, in addition to translating strategy into tactics, priorities and resource requirements.
- Actively serve as a key member of the Branchburg/Carlsbad Operations Leadership Team ensuring a comprehensive manufacturing strategy and infrastructure in support of Roche Diagnostics worldwide.
- Represent Global Operations on the GenMark leadership Team responsible for strategizing, endorsing and aligning on people and culture topics impacting all Roche employees at the Carlsbad Site.
- Responsible for all equipment and automation capital expenditures and site development while ensuring compliance to all Roche and global regulatory standards and regulations.
Vice President, Operations
Roche Diagnostics
Branchburg
01.2005 - 10.2024
- Spearheaded the transfer of Point-of-Care (POC) Liat Manufacturing from Marlborough, MA to the Branchburg, NJ Site, resulting in a reduction of standard manufacturing costs by over 75%.
- Increased capacity of the X800 and LIAT product lines by 7-fold and 15-fold, respectively, to meet COVID-related demands.
- Focused on improving profitability margins and leading internal organizational change.
- Managed all Operations activities, including filling, final packaging, engineering support, production planning, logistics, project management, warehousing, facilities, technical services, validation, and distribution of PCR-based diagnostic and research kits.
- Ensured compliance with all international regulatory requirements (GMP, QSR, ISO, OSHA, IVDD).
- Held administrative and budgetary accountability for over 500 employees.
- Created and implemented a strategy for remediation, continuous improvement and culture transition.
- Oversaw yield improvement initiatives and managed capital projects valued up to $100 million.
Senior Director of Operations
Roche Diagnostics
Belleville
11.1999 - 01.2005
- Directed all operational activities for the manufacture of IVD products, including aseptic filling and final packaging, at two sites in New Jersey.
- Managed comprehensive end-to-end supply chain functions, encompassing production planning, warehousing, and global logistics for diagnostic and research kits.
- Provided strategic oversight for all manufacturing-related engineering support, ensuring process efficiency and reliability across the two New Jersey sites.
- Accountable for the overall quality system, including the management and execution of the validation program (IQ/OQ/PQ) for new equipment, processes, and facility modifications to ensure strict compliance with international regulatory requirements (GMP, QSR, ISO).
- Led a multidisciplinary team to drive continuous improvement initiatives, cultural transformation, and consistent on-time delivery.
Director of Engineering
Roche Diagnostics
Belleville
01.1997 - 10.1999
- Directed all engineering, validation, and maintenance activities for manufacturing operations, ensuring compliance as a key IVD manufacturer within the FDA-regulated environment.
- This involved providing strategic oversight for all primary and secondary packaging engineering, including equipment selection, installation, optimization, and ongoing maintenance for high-throughput diagnostic kits.
- I was accountable for all equipment engineering, encompassing process and utility systems, from conceptual design and commissioning through validation and sustaining maintenance.
- Furthermore, I managed and executed the entire validation program (IQ/OQ/PQ) for all new and modified manufacturing equipment and processes to ensure quality and regulatory compliance, and collaborated with R&D and Manufacturing to implement process improvements that enhanced efficiency and reduced material waste.
Reengineering/SAP Team Lead
Roche Diagnostics
Branchburg
12.1995 - 01.1997
- Participated in strategic planning sessions to align team goals with organizational objectives.
Senior Packaging/Project Manager
Roche Diagnostics
Belleville
01.1992 - 12.1995
Industrial Engineer
Roche Diagnostics
Nutley
01.1989 - 01.1992
Education
Leadership Program -
London Business School
01.2002
Master of Science (M.S.) - Financial Management Services
New Jersey Institute of Technology
New Jersey01.1993
Bachelor of Science (B.S.) - Industrial Engineering
New Jersey Institute of Technology
New Jersey01.1990
Skills
- Operational Development
- Agile Manufacturing
- Regulatory Compliance
- Strategic Planning
- Cultural Advancement
- Supply Chain Management
- Project Management
- Change Management
- Facility Design and Setup
- Automation Strategy
Specialties
- Operational Development
- Agile Manufacturing
- Regulatory Compliance
- Strategic Planning
- Cultural Advancement
- Supply Chain Management
- Project Management
- Change Management
- Facility Design and Setup
- Automation Strategy
Timeline
Vice President, Operations
Roche Diagnostics
10.2024 - Current
Vice President, Operations
Roche Diagnostics
01.2005 - 10.2024
Senior Director of Operations
Roche Diagnostics
11.1999 - 01.2005
Director of Engineering
Roche Diagnostics
01.1997 - 10.1999
Reengineering/SAP Team Lead
Roche Diagnostics
12.1995 - 01.1997
Senior Packaging/Project Manager
Roche Diagnostics
01.1992 - 12.1995
Industrial Engineer
Roche Diagnostics
01.1989 - 01.1992
Leadership Program -
London Business School
Master of Science (M.S.) - Financial Management Services
New Jersey Institute of Technology
Bachelor of Science (B.S.) - Industrial Engineering
New Jersey Institute of Technology