Technical Consultant

• May 2023 - Present

To provide technical consultancy on sustainable project management and quality management system on biotechnology-based issues. Consulting topics are the following:• Establishment of ISO 13485 quality management system.• Establishment of ISO 14971 quality management system.• Establishment of ISO 9001 quality management system.• Establishment of QDMS documentation system.• Establishment of a laboratory management system.• CE-IVD certification.• Realization of UTS registrations of a product.• Preparation of technical file of a product.• Prepare application files and progress reports for TÜBİTAK, KOSGEB, Ministry of Trade, and Industry Guided BAP projects.• Consulting on R&D (5746) and Technopark legislation (4691).• Ensuring internal and external audit coordination.• Patent search and preparation of the application file. Show less

Business Development Manager

• Feb 2020 - May 2023

It is a start-up R&D company, and it operates in developing biosimilar drugs, probiotics, and medical devices and meeting the device and consumable needs of laboratories in the biotechnology sector. My responsibilities in the company are as follows:• To lead the quality team to integrate ISO 13485, ISO 14971, ISO 14644, and ISO 9001.• To create job descriptions and company organizational charts.• To establish the R&D laboratory and production infrastructure for medical device diagnostic kits.• To create and follow the calibration and maintenance plans.• To carry out CE-IVD and product certification studies.• Prepare a Product Information File (PIF).• To follow MDR, In-vitro medical devices, and TITCK legislation.• To perform UTS records and to keep them up-to-date.• To prepare project application files for Industry Guided BAP, TUBITAK, KOSGEB, and Development Agencies, to make referee presentations.• To ensure the necessary coordination for the progress of the projects by the work-time plan.• To follow the project objectives and prepare progress reports.• To develop project collaborations with universities, research centers, public institutions, organizations, and private sector companies.• To prepare periodic technical and financial reports for TÜBİTAK and KOSGEB projects to make audience presentations.• To determine the technical specifications related to the project outputs and to create the necessary files.• Prepare the contract texts to transfer financial rights related to the projects and negotiate with the relevant parties.• To follow the patent application process within the scope of the projects to prepare the necessary files.• To determine the roadmap for the commercialization of the project outputs.• To create workflows on purchase orders, warehouse, stock management, and customer orders on Netsis.• Prepare monthly and annual periodic reports of the branch established in Manisa Technopark within the framework of law #4691. Show less

Deputy General Manager

• Jul 2018 - Feb 2020

I worked first as the project team leader and then as the Assistant General Manager at Investa Global Consulting, a group company of Sistem Global Consulting. I provided R&D and project consultancy to large-scale and SME-scale companies throughout Turkey, especially in the Aegean region. My duties are, in summary:• To give information seminars and training on grant support mechanisms.• Receiving and evaluating feedback on current customers' satisfaction.• Developing marketing arguments to win new customers.• Converting consultancy offers into contracts.• To provide consultancy to 50+ private sector companies within the scope of R&D and Design Center analysis, application, audit, and maintenance services within Law No. 5746.• To prepare an investment feasibility report of 500 million TL and a project application within the scope of the Technology Oriented Industry Move Program of the Ministry of Industry and Technology.• To prepare two approved investment feasibility reports and project applications within the scope of KOSGEB Techno-Investment and Strategic Product programs.• To prepare two approved investment feasibility reports and project applications within the scope of the ZAFER Development Agency and South Aegean Development Agency.• To prepare training programs within the scope of Development Agencies Technical Assistance.• To prepare 45+ project application files for TÜBİTAK 1501, 1507, 1511, 1512, 1513, 1514, 1505, and 1601 programs.• To prepare 15+ project application files within the scope of KOSGEB R&D and Innovation, KOBIGEL, and Foreign Market programs.• To prepare four project application files for the Ministry of Commerce Design and Product Development and Global Supply Chain (KTZ) programs.• To lead the quality team in ISO 27001 and ISO 9001 certification studies.• To follow individual and company targets, make budget studies, and analyze income-expense reports. Show less

Team Leader

• Dec 2017 - Jul 2018

Project Coordinator

• Sep 2014 - Dec 2017

My responsibilities at Quantag Nanotechnology, which was established as a spin-off company of Opet Petrolcülük A.Ş., a subsidiary of Koç Holding, within the body of İzmir Institute of Technology (İYTE) Technopark for more than three years since its establishment, are as follows: • To prepare 3 TUBITAK 1501 R&D project application files regarding Quantum dot technology as marker-based in functional fluids such as mineral oil and fuel oil and to take various roles in these projects as a team member. • To prepare referee presentations, audience presentations, technical and financial period reports, and final project reports of TUBITAK projects. • To prepare the Safety Data Sheets (MSDS) and Technical Data Sheets (TDS) of the project output products. • I have a registered patent related to the projects. US Patent #10369538-B2: “Flow System and Process For Photoluminescent Nanoparticle Production.” • Using testing and equipment such as a spectrophotometer, DLS particle size, continuous flow reactor, and Advanced-Flow™ reactor (AFR). • To carry out teamwork on innovative product development with the TRIZ method. • To lead the quality team for ISO 16949 and ISO 9001 studies. • To prepare the monthly and annual reports of the company located in Technopark within the scope of the law numbered 4691. • To receive and implement the necessary training of IATA on transporting dangerous goods by air. Show less

Product Development Engineer

• Jan 2012 - Sep 2014

As a result of the partnership of Opet Lubricants, where I have been working as an R&D Engineer since 2007, with the German Fuchs company, I transferred to the Product Development Department, a newly established department, according to the changed organizational structure. As a Product Development Engineer, my work with almost all departments of the company is as follows: • To use SAP's Production Planning (PP), Materials Management (MM), and Quality Management (QM) modules. • Examining competitor products with the Sales & Marketing department, revealing their similarities and superiorities (GAP Analysis), making comparisons, and creating new product demand. • To follow trends, determine new approvals, and abandon unnecessary approvals with the Technical Service department. • To investigate production problems together with the R&D department. • Review the tests with the quality control department to shorten the test times. • Led the ISO 16949 studies with the quality department, creating and coordinating the project teams. • Developing lean manufacturing techniques with the production department, making production and packaging operations efficient by creating bulk product codes, and increasing overall equipment efficiency (OEE). • To conduct re-evaluation studies of idle stocks that have been out of production with the planning department, make raw material planning, and ensure that product transitions are coordinated.• Conduct total productive maintenance (TPM) studies with the maintenance department. • To make SAP developments with the IT department. • To prepare FMEA and PPAP files to lead the team. • Researching REACH and CLP legislation, determining actions. • To follow new developments about lubricants, report, and make decisions. • Checking product labels. • Checking technical specifications and approvals in Technical Data Sheets (TDS). • Developing EBA workflows and QDMS quality documentation system. Show less

Research and Development Engineer

• Jan 2007 - Jan 2012

• Gaining laboratory and testing experience: Being able to independently perform all tests related to lubricants such as engine oils, gear oils, ATF, hydraulic oils, and industrial oils. • I have extensive knowledge of lubricant formulations from participating in the "Fluid Technology Seminar" training at the facility of Lubrizol in Hazelwood (UK). • Prepare the Safety Data Sheets of the products. • To prepare and control the technical label information of the products. • To use SAP's PP, MM, and QM modules. • To make TSE and OEM approval applications for products, follow approval periods, and keep them up to date. • Prepare plans and documents on ISO 17025. • Getting all ISO 16949 Core Tools training: APQP-Advanced Product Quality Planning, FMEA-Failure Mode and Effects Analysis, MSA-Measurement System Analysis, PPAP-Production Part Approval Process, SPC-Statistical Process Control. • To develop products and to carry out field inspection activities within the framework of the FORD Q1 document. • To work on Ford's G8D-Global Eight Discipline problem-solving method. • To use GPDS-Global Product Development System. • To realize four projects within the scope of Lean Six Sigma (yellow belt). • To research production nonconformities. • To carry out harmonization studies on the EFQM-Excellence Model for Quality Management. • To participate in ISO 16949 and ISO 9001 internal audits, create audit plans and prepare audit reports. • Participate in the new product commissioning processes to finalize and report customer-termed works. • To use QDMS software. • To use the EBA workflow program to create workflows on issues such as new product development, documentation requests, purchasing processes, job assignments, and annual leaves. • To use the SAP program's QM, MM, and PM modules. • To prepare 4 R&D project application files supported by TUBITAK, to make referee and audience presentations, to prepare technical and financial reports, and to prepare final reports. Show less

Engineering Intern

• Jul 2004 - Jul 2004

Potassium clavulanate, an antibiotic substance, is fermented at the DEPA Pharmaceutical Factory. During my internship, I studied this production process. Potassium clavulanate is produced using microorganisms developed in the microbiology laboratory in fermentation. Then this clavulanic acid is precipitated by adding potassium salt after applying a series of separation/purification processes such as filtration, separation, evaporation, sedimentation, and centrifugation. It is obtained by turning it into a white crystalline powder, drying it, and packaging it. Show less