ARNAN BEN-DAVID - CV

2018

Independent Principal consultant in the field of sterile engineering (10AR – Sterile Engineering Solutions)

Provide support to sterile manufacturing companies in all aspects of engineering – design, initiation, conceptual, equipment, systems, facilities, processes, qualifications, maintenance, troubleshooting.
More than 10 clients so far including the companies: Teva, Omrix, BiondVax, NeuroDerm, Polypid

2013 - 2018

Teva Pharmaceutical Industries | Director – Global Engineering Sterile production network

Sterile production technologies expert for all sterile production and R&D network in Teva (12 sites)
Focal point for knowledge sharing. Creation of collaboration, establishment of communities of practice for knowledge sharing and standardization.
Ongoing support to the sterile network in projects, production issues and operations
Introduction of new technologies and assimilating them in production processes. Detail design of automatic production processes
Global standards and guidelines writing. Creation of URS’s and technical specifications
Approval of sites CAPEX plans.

2008 - 2013

Omrix Biopharmaceuticals (After the acquisition by JnJ) | Director – strategic projects

Company integrator for engineering activities or technology transfer between Omrix and other JnJ sites
Technical support and holistic overview of engineering activities
Feasibility studies for transferring products between sites of JnJ
Participating in Due-diligence between JnJ and other companies

Projects

Project Manager - Transfer of lyophilized product from Israel to an abroad site. Transfer of production process, performing complex logistics processes, acquiring quality and regulatory approvals (FDA, EU) until the product reaches JnJ distribution warehouses in the US
Project Manager - Transfer the production of the biological glue syringe to another company to reduce costs
SME in the construction of 3 sterile manufacturing facilities

1998 - 2008

Omrix Biopharmaceuticals | Chief engineer and Engineering department manager

Responsible for all engineering activities in the plasma fractionation plant, aseptic filling lines and R&D laboratories
Establishment of engineering department:
- Recruitment of employees
- Establishment of all engineering infrastructure systems
- Establishment of calibrations department - laboratory, standards and calibration management computerized system
Establishment and management of the validation department, including the establishment of the methodology and procedures
Management of the IT unit (including preparation of the company for Bug 2000 and compliance with SOX requirements)
Management of the Company's CAPEX budget
Participation in the writing of the BLA for the biological glue and participation in meetings with the FDA for approval of the product
Representation of engineering during inspections of the FDA and MCA authorities for marketing approval
Representing the company in front of a Japanese Red Cross plasma component manufacturing facility on cooperation and technology transfer

Projects

Establishment of a new production plant in Jerusalem for the production of biological glue. Over 8,000 square meters of clean manufacturing rooms, laboratories, technical areas and offices:
- 3X Scaling up of the production process
- Building the factory concept
- Responsibility for the construction
- SME of equipment and systems
Stage II of the project - Addition of a production suite and a sterile filling suite including a lyophilizer
Participation in the development of the Fibrin Pad product on behalf of JnJ
Participation in the design and development of an inovative application machine for the Fibrin Pad (built by Harro Hofliger)
Improvements in the biological glue syringe and the development of a new, more ergonomically and designed pressure regulator for the syringe activation
Optimization of production processes in the fractionation plant according product mix and for efficiency improvement
Establishment of a new plant for manufacturing of the Fibrin pad
- construction of sterile plant with low humidity (30% RH)
- Installation of the application machine in the plant
- Transforming of Albumin production line to IVIG production line.
- 3X scale up of the production process of biological glue
- Addition of nanofiltration phase in the IVIG process
- Increasing the production capacity of the fractionation facility

1994 -1998

Teva Pharmaceutical Industries | Project manager, SME for equipment, instrumentation, control systems and calibrations

SME of production technologies:
Sterile - autoclaves, depyrogenation oven, lyophilizers, automatic visual inspection machine, Sterility testing isolator
Dry production - Fluid bed drier, High shear mixer, V-mixer, coaters
Calibration Department Manager - Activities and Procedures
Divisional SME for instrumentation and control systems

Projects

Project Manager of purchasing, installation and qualifications of granulation equipment in a New Dry Production Plant in KS
Upgrading of control systems of legacy production equipment by adding PLC’s for execution of automatic production processes and printing production reports
Purchase and installation of an automatic visual testing machine for lyophilized Copaxone
Establishment of a new calibrations laboratory in Kfar Saba site

1988 - 1993

Abic | maintenance department manager

Responsible for all maintenance activities in the pharmaceutical plant (sterile, dry production, semi solids, syrups and packaging), the chemical plant, the veterinary products unit and the veterinary vaccine plant
Maintenance of chemical and microbiological laboratories
Management of 26 people
Construction of maintenance systems - computerized management system, procedures and training

Projects