ANIL AGICI
Biocompatibility Engineer
Summary
Forward-thinking planner ready to apply expertise from 5+ year career focused on advancing market share of biotechnological products and medical devices. Expert project coordinator with proven industrial knowledge and excellent communication skills. Well-versed in monitoring and capitalizing on both internal and external trends. Talented researcher, skilled at contributing to team success and meeting strict deadlines. Adapts quickly to new needs and policies. Reliable candidate ready to take on challenges in a position using problem-solving and task prioritization skills to help team succeed.
Overview
13
13
years of professional experience
4
4
Certifications
Work History
Biocompatibility Engineer
Getinge Cardiopulmonary
11.2023 - Current
- Compliance to ISO 10993 regulation series,
- Biocompatibility assessor of Class III cardiopulmonary disposable medical devices for chemical and biological safety,
- Successful conducting of chemical characterization, cytotoxicity and hemocompatibility tests for the new Medical Device Regulation (MDR) 2017/745/EU,
- Successful integration of technical file documentation for the new Medical Device Regulation (MDR) 2017/745/EU,
- 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.
R&D Engineer
Getinge Cardiopulmonary
7 2021 - 11.2023
- Being part of multinational projects and management of various projects
- Compliance to ISO 11658, ISO 13485, ISO 15674, ISO 15675 and ISO 15676 Regulations
- Successful integration of test method validations and verifications for the new Medical Device Regulation (MDR) 2017/745/EU
- Created test instructions, plans and reported on test method validations
- Successful integration of technical file documentation for the new Medical Device Regulation (MDR) 2017/745/EU
- Formulate solution on critical strategies during MDD-to-MDR transition to save time and a cost of additional application fee for a new technical documentation, providing guidance on company policies for MDR
- Coordinating multinational projects that aims to integrate the requirements of MDR 2017/745/EU
- Generated novel ideas for new solutions by spearheading brainstorming sessions
- Managed research laboratory, including equipment, supplies, and recordkeeping.
Product Manager
HerAda Health Technologies
10.2019 - 11.2020
- Created product promotion plans and marketing initiatives to increase brand awareness
- Modernized products based on consumer feedback and market analysis to increase sales and expand product offering
- Directed market planning and research to identify new business opportunities
- Supported all sales team members to drive growth and development
- Strategized approaches to meet objectives and capitalize on emerging opportunities
- Forecasted sales numbers and product profitability to determine ideal strategies
- Built close relationships with key customers, thought leaders and industry influencers to stay abreast of emerging market trends and applications.
Business Development Specialist
Innovative Biotechnology Organization LTD
10.2018 - 10.2019
- Motivated sales team and generated engagement by hosting team-building events
- Developed relationships with potential clients to gain momentum for account development opportunities
- Provided assistance to prospective clients to encourage high level of customer service
- Researched potential business opportunities in new and existing markets
- Partnered with team members in other business functions to establish best possible solutions
- Analyzed consumer behaviors and market trends, adjusting email and advertising campaigns based on current knowledge.
Protein Analyst
Turgut İlaçları A.Ş
09.2017 - 10.2019
- Worked closely with team members to deliver project requirements, develop solutions and meet deadlines
- Created agendas and communication materials for team meetings
- Wrote SOP's for correct implementation and application of laboratory procedures
- Analyzed proteins and impurities after recombinant protein production
- Improved operations by working with team members and customers to find workable solutions.
Medical and Regulatory Affairs Specialist
TNC Medicine Research
12.2016 - 09.2017
- Produced and filed applications and related documentation for regulatory procedures
- Organized and maintained all files related to regulatory actions
- Evaluated changes to documents submitted to determine need for amendments
- Oversaw and coordinated human clinical studies
- Liaised with contacts such as pharmaceutical companies.
Scientific Support Specialist and Research Assistant
Suleyman Demirel University
03.2011 - 03.2012
- Worked at the Stem cell laboratory
- Duties included: Laboratory equipment and sample maintenance, sample and equipment preparation with the use of aseptic techniques
- Worked at Medical Genetics laboratory
- Duties included: Analysis, integration and processing of high-throughput biomedical data, develop innovative concepts and theories based on available data on patients, DNA sequencing (Pyrosequencing), Gel electrophoresis
- Personally helped to obtain a transilluminator in a month which was malfunctioning and could not be replaced for nine months prior to my employment.
Education
Master of Science - Proteomics, Medical and Molecular Biotechnology, Recombinant Technology, biochemistry, bioethics and bioinformatics
Macquarie University
Sydney, AustraliaGraduate Certificate of Biotechnology - undefined
Macquarie University
Sydney, AustraliaBSc Honours - undefined
The University Of Nottingham
Nottingham, UKSkills
Biotechnology
Tactical Planning
Time Management
Team Leadership and Management
Product Launch
GMP, GLP, GDP
Project scope analysis
Resource allocation
Written and verbal communication
Design development
Research presentation
Certification
- Coaching Skills for Leaders and Managers, Linked-in (10/01/2022)
- Medical Device Regulation training, T
Additional Information
Member of Society of Medical Genetics, Molecular Cancer Research Society (MOKAD), 2015/03/26 RSA (SITHFAB201 Provide Responsible Service of Alcohol), 2009 Driver's License
References
References may be provided upon request
Timeline
Biocompatibility Engineer
Getinge Cardiopulmonary
11.2023 - Current
Product Manager
HerAda Health Technologies
10.2019 - 11.2020
Business Development Specialist
Innovative Biotechnology Organization LTD
10.2018 - 10.2019
Protein Analyst
Turgut İlaçları A.Ş
09.2017 - 10.2019
Medical and Regulatory Affairs Specialist
TNC Medicine Research
12.2016 - 09.2017
Scientific Support Specialist and Research Assistant
Suleyman Demirel University
03.2011 - 03.2012
R&D Engineer
Getinge Cardiopulmonary
7 2021 - 11.2023
Master of Science - Proteomics, Medical and Molecular Biotechnology, Recombinant Technology, biochemistry, bioethics and bioinformatics
Macquarie University
Graduate Certificate of Biotechnology - undefined
Macquarie University
BSc Honours - undefined
The University Of Nottingham
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