HÜSAMETTİN ÖZDEMİR
R&D ASSISTANT MANAGER
Tekirdağ,59
Summary
Proven leader in R&D with a track record of steering teams towards innovation at DEVA HOLDİNG, adept in experiment design and team collaboration. Excelled in securing FDA approvals and enhancing product quality through meticulous analytical method development. Demonstrates exceptional problem-solving and team leadership, ensuring regulatory compliance and operational excellence. Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth. Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth. Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
18
18
years of professional experience
Work History
R&D ASSISTANT MANAGER
DEVA HOLDİNG
01.2020 - Current
- Oversee and manage four teams, each comprising approximately ten members, including team leaders, with a total of around 40 team members.
- Responsible for preparing the analytical sections of registration files for FDA, EU, and Turkish regulatory authorities.
- Conduct research on alternatives and resources for the improvement of commercially available products and to enable their production under more economical conditions.
- Successfully obtained FDA approval for a complex formula eye drop product.
- Recently received FDA approvals for two solution-form products.
- Achieved FDA approval for a lyophilized pharmaceutical product.
- Coordinate and organize the validation of analytical methods and the preparation of CTD (Common Technical Document) parts.
- Address inquiries from regulatory authorities, ensuring timely and accurate responses.
- Actively contributed to obtaining FDA approvals for 7 products across various dosage forms, including emulsions (complex drug category), solutions, and lyophilized pharmaceuticals.
- I am actively involved in the FDA registration process of 4 additional products, for which we are preparing complete response letters
- I have been actively involved in the preparation of the analytical sections for numerous registration dossiers submitted to the Turkish Ministry of Health for solid, liquid, and semi-solid dosage forms, including capsules, tablets, eye drops, and injectable products, as well as in responding to the Ministry's requests throughout the process.
- I have been involved in advancing and managing specific processes related to glass delamination, elemental impurities, nitrosamine, and extractable/leachable studies
- I have additional experience with products contained in LDPE bottles and the issues encountered with them.
R&D Development Chief
DEVA HOLDİNG
01.2016 - 01.2020
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Proven ability to learn quickly and adapt to new situations.
- Skilled at working independently and collaboratively in a team environment.
- I worked as a supervisor for 4 years, leading a team of 10 people. During this period, I was responsible for preparing the analytical sections of registration dossiers, developing and validating analytical methods, and keeping track of pharmacopoeias, while ensuring that any updates were communicated to the team. I was also involved in training team members and addressing improvement requests at the commercial manufacturing site. Additionally, I participated in the development processes of products with solid, liquid, and semi-solid dosage forms (capsules, tablets, eye drops, lyophilized, parenteral, solutions, ovules) for submission to regulatory authorities in Turkey, the US, and the EU
Senior Analytical Development Specialist
DEVA HOLDİNG
01.2014 - 01.2016
- During my tenure as a Senior Specialist, I contributed to the preparation of analytical sections for drug registration dossiers submitted to regulatory authorities in the EU, US, and Turkey. I was involved in developing and validating methods using HPLC, GC, AAS, ICP-OES, and LC-MS instrumentation. Additionally, I supported the training processes of new team members and conducted troubleshooting investigations for products reported to have issues.
- Developed individualized and group programming and safety plans in support of academic achievement.
- Administered government-supported community development programs and promoted department programs and services.
- Revamped legacy giving program designed to encourage planned gifts from supporters who want their support outlast them after they pass away.
- Identified new sources of funding through meticulous research of local, regional, national foundation databases, corporate giving programs, government grants worth millions of dollars annually.
R&D Development Specialist
DEVA HOLDİNG
11.2011 - 01.2014
- As an Analytical Development Specialist, I played a key role in the creation of analytical sections for pharmaceutical registration dossiers submitted to regulatory authorities in the EU, US, and Turkey. My expertise includes developing and validating analytical methods utilizing advanced instrumentation such as HPLC, GC, AAS, ICP-OES, and LC-MS. I also facilitated the onboarding and training of new team members, enhancing their skills in method development and problem-solving. Additionally, I conducted comprehensive investigations to identify and resolve issues related to products, ensuring compliance with regulatory standards and quality assurance.
- Developed individualized and group programming and safety plans in support of academic achievement.
- Administered government-supported community development programs and promoted department programs and services.
- Revamped legacy giving program designed to encourage planned gifts from supporters who want their support outlast them after they pass away.
- Increased grant funding by researching, writing, and submitting compelling grant proposals to various foundations and corporations.
Quality Control Analyst
Nobelfarma Pharmaceutical Company
01.2007 - 11.2011
- I started my career in the pharmaceutical industry in a quality control laboratory, where I performed analyses on finished products, raw materials, and stability testing. I actively conducted HPLC, GC, and dissolution analyses in compliance with GMP (Good Manufacturing Practice) standards. With the increasing importance of data integrity, I played a significant role in the integration of the SDMS (Scientific Data Management System) into the laboratory, ensuring accurate data management and regulatory compliance
- Improved overall production efficiency by identifying and resolving quality control issues.
- Enhanced product quality by conducting thorough analyses and implementing corrective actions.
- Inspected items and compared against standards to meet regulatory requirements.
- Maintained a safe working environment, adhering to safety regulations and proper handling of hazardous materials.
Education
Bachelor of Science - Chemistry
Abant İzzet Baysal University
Bolu, Turkey 04.2001 -
Skills
Design thinking
Experiment Design
Intellectual property
Planning and scheduling
Teamwork and Collaboration
Problem-Solving
Time Management
Problem-solving abilities
Team Leadership
Decision-Making
Planning and coordination
Prototyping
Timeline
R&D ASSISTANT MANAGER
DEVA HOLDİNG
01.2020 - Current
R&D Development Chief
DEVA HOLDİNG
01.2016 - 01.2020
Senior Analytical Development Specialist
DEVA HOLDİNG
01.2014 - 01.2016
R&D Development Specialist
DEVA HOLDİNG
11.2011 - 01.2014
Quality Control Analyst
Nobelfarma Pharmaceutical Company
01.2007 - 11.2011
Bachelor of Science - Chemistry
Abant İzzet Baysal University
04.2001 -