Production and Technology Transfer Assistant Manager

• Jan 2023 - Present

Product Development/Technology Transfer and Validation Chief

• Nov 2019 - Feb 2023

Participate in troubleshooting existing problem formulations and suggest, implement and validate suitable improvements.To assist in coordinating technical transfers and scale up of products from World Medicine R&D/ Pilot Plant into the Manufacturing facility at World Medicine Çerkezköy facility.To participate in the timely execution of Trial and Validation batches including the writing, review and approval of validation protocols and reports. To ensure that deadlines are met and all correct sampling is carried out.To assist in the transfer of products from other manufacturing sites worldwide into site Manufacturing department and assist in the transfer of products from Wold Medicine to other manufacturing sites.To assist in Technical Investigations where required and to write, review and approve Investigation reports.To assist in the timely sourcing of Manufacturing equipment and tooling required for new products or as a result of process improvement initiatives.To act as change agents by gaining support for and driving sustainable improvements in ways of work. Show less

Enterpreneur/ lnventor

• Dec 2018 - Oct 2019

Senior Formulation Development Engineer

• Jun 2015 - Dec 2018

• Responsible for product development of all HA products including. • Responsible for product development of hydrophilic and hydrophobic iol lens raw materials. • Purification of monomers such as distillation , recrystallization • Preparing buffers and pH buffer agents in C class sterile plant., • Filtration process and neutralization process design, thermal steam sterilization process, draw flowcharts for manufacturing processes • Assist Supply Chain and Purchasing Departments to find new supplier and meeting with suppliers • Developing pre-formulation and newest generic drug formulations for BA/BE studies. • Prepare and validate pilot manufacturing process protocols and prepare reports to implement in CTD • Creating budgets, submitting required documents and follow up of project steps at the scope of TUBİTAK collaboration • To create new, challenging patent ideas for new products to be developed (Freedom to operate) Show less

R&D Formulation Development Specialist at DEVA

• Oct 2010 - Jun 2015

• Responsible for the new product formulation development sterile , nonsterile (solid, liquid, semisolids), sterile inhaler, oncology to β-lactam drug product range. • The use of knowledge of all laboratory equipment ( Coating machine, capsule filling machine tablet pressing machine , welt granulation , fluid bed ( Vector ) especially knowledge of the effervescent ,MR ,XR , ODT tablet manufacturing & formulations ,bilayer tablets ,suspensions ,vitamins, nebul inhalation solutions, veterinary products and development of new product and generic product, analytical method development and validation. Pilot production and process validation of the product. • To attend prospective validation stages for new products to be submitted, creating validation reports Show less

R&D process engineer at Neutec

• Nov 2009 - Oct 2010

• HPLC , GC and Dissolution device for analysis • Responsible for the Coordination of manufacturing and R&D activities ,pilot batches , scale batches • Method development and validation • Pre formulation of effervescent tablet , Film Tablet , • Using vector fluid bed for granulation • HPLC , GC and Dissolution device for analysis • Responsible for the Coordination of manufacturing and R&D activities ,pilot batches , scale batches • Method development and validation • Pre formulation of effervescent tablet , Film Tablet , • Using vector fluid bed for granulation

Sales Support

• Nov 2006 - Jul 2008

• Responsible for the selling of all technical equipment, analytical devices and consumable laboratory products , Technical service for equipment • Responsible for the selling of all technical equipment, analytical devices and consumable laboratory products , Technical service for equipment

Chemist Teacher

• Jan 2005 - Dec 2006

Responsible for the teaching of chemistry pre-university Responsible for the teaching of chemistry pre-university

Trained

• Jan 2005 - Jun 2005

Zinc Carbonate Enhancement Method ( Kayseri -Develi ) Zinc Carbonate Enhancement Method ( Kayseri -Develi )

Trained

• Jul 2004 - Sep 2004