R&D Manager from World Medicine, Turkey
Dr. Cem Çalışkan is an accomplished R&D Manager and pharmaceutical researcher with a distinguished background in analytical chemistry, method development, and regulatory compliance. His professional journey is marked by extensive contributions to the pharmaceutical industry, particularly in analytical method validation, formulation development, and laboratory accreditation processes. With over a decade of progressive experience, Dr. Çalışkan has held key roles at leading pharmaceutical organizations including World Medicine and Neutec İlaç, consistently driving innovation and excellence in pharmaceutical R&D. His academic background features a Ph.D. in Analytical Chemistry from Yıldız Technical University, complemented by a Master’s degree in Organic Chemistry and ongoing Executive MBA studies at Istanbul University, reflecting a multidisciplinary approach to science and leadership. Dr. Çalışkan’s portfolio includes several peer-reviewed publications in top scientific journals, where he explores themes such as nitrosamine detection, impurity profiling, stability-indicating methods, and in-vitro drug release. His research not only addresses critical analytical challenges but also aligns with global regulatory standards. With a passion for mentoring, scientific rigor, and innovation, Dr. Çalışkan exemplifies the integration of academic excellence and industrial impact, making him a strong candidate for scientific recognition at the international level.
Professional Profile
Education
Dr. Cem Çalışkan has a comprehensive and interdisciplinary educational background that has shaped his expertise in analytical and organic chemistry as well as pharmaceutical development. He earned his Doctor of Philosophy (Ph.D.) in Analytical Chemistry from Yıldız Technical University between 2018 and 2022, where he focused on advanced analytical techniques and pharmaceutical applications. His doctoral work provided the foundation for several high-impact scientific publications and patents in method validation and impurity analysis. To complement his scientific expertise with managerial insight, Dr. Çalışkan is currently pursuing an Executive MBA at Istanbul University (2024–present), focusing on strategic business management and leadership in the pharmaceutical industry. His academic journey also includes a Master of Science in Organic Chemistry from Sakarya University (2014–2016), where he deepened his understanding of chemical reactions, drug formulation, and molecular mechanisms. He holds a Bachelor of Science in Chemistry from Uludağ University (2003–2009), which laid the initial groundwork for his professional path in R&D. This strong academic progression, spanning both the sciences and management, enables Dr. Çalışkan to bridge the gap between innovative research and strategic decision-making in the pharmaceutical sector.
Professional Experience
Dr. Cem Çalışkan’s professional experience reflects a sustained commitment to innovation and quality in pharmaceutical research and development. Since 2020, he has been serving as the R&D Manager at World Medicine, where he leads cross-functional teams in analytical development, method validation, and compliance with international regulatory standards. In this role, he initiated the patented WMINOLAB analytical service model, exemplifying his vision for high-quality, independent R&D frameworks. Prior to this, from February to August 2020, he held the position of R&D Analytical Development Chief at the same organization, coordinating sustainable business process models, documentation systems, and team development initiatives. Between 2013 and 2020, Dr. Çalışkan worked as an R&D Responsible Specialist, playing a critical role in analytical method development, stability testing, and responding to regulatory queries from global authorities. Earlier in his career, he served as a Process Development Analyst at Neutec İlaç (2011–2013), where he conducted formulation trials, transfer validations, and documentation for CTD Module III. These roles have not only honed his technical capabilities but also highlighted his strategic thinking, regulatory insight, and project management skills in both domestic and international pharmaceutical landscapes.
Research Interests
Dr. Cem Çalışkan’s research interests center on pharmaceutical analytical chemistry, with a special focus on developing novel methods for impurity profiling, drug stability studies, and nitrosamine risk assessment. He is deeply engaged in creating robust and regulatory-compliant analytical methodologies using cutting-edge instruments such as LC-MS/MS, RP-HPLC, and FTIR spectroscopy. His scientific inquiries aim to improve the accuracy, reproducibility, and efficiency of pharmaceutical testing methods, ensuring safer and more effective drug formulations. A key area of his work involves validating stability-indicating methods for various drug compounds, exploring the physicochemical behavior of active pharmaceutical ingredients (APIs) and excipients under stress conditions. He is also involved in studies on in-vitro drug release, polymer membrane permeability, and analytical compatibility of formulation components. In recent years, Dr. Çalışkan has broadened his scope to include the assessment of genotoxic impurities and packaging-related contaminant analysis, which are critical in modern pharmaceutical safety regulations. His interest in bridging laboratory innovation with regulatory frameworks is reflected in his leadership of accredited research labs and method development teams. This intersection of research excellence and industry relevance defines his contribution to the evolving landscape of pharmaceutical sciences.
Research Skills
Dr. Cem Çalışkan possesses a broad and advanced skill set in pharmaceutical R&D, particularly in the analytical domain. His technical proficiency includes the use of LC-MS/MS, RP-HPLC, FTIR, UV-Vis spectroscopy, and gravimetric analysis for method development, validation, and impurity determination. He is well-versed in Good Laboratory Practice (GLP) and has led numerous method validation studies, including for high-risk pharmaceutical substances like nitrosamines and complex impurities. His skills extend to process optimization, formulation compatibility testing, and the analytical transfer of drug products across laboratories and regulatory environments. Dr. Çalışkan also excels in scientific documentation, protocol writing, and preparation of CTD Module III files for regulatory submission. Beyond technical expertise, he has notable experience in project management, cross-departmental coordination, and team training, equipping him to lead dynamic research teams. His communication skills support effective regulatory correspondence with ministries and international partners, while his analytical thinking aids in critical decision-making across all stages of pharmaceutical development. Combined, these research skills make him not only a technically sound researcher but also an effective scientific leader.
Awards and Honors
While specific awards and honors are not listed in his current profile, Dr. Cem Çalışkan’s career accomplishments reflect a reputation for research excellence and industrial innovation. His leadership in the development and implementation of WMINOLAB, a patented analytical service platform within World Medicine, stands as a testament to his ability to deliver novel, scalable solutions to industry-wide challenges. His publications in reputable journals such as the Journal of Pharmaceutical Sciences, European Journal of Mass Spectrometry, and Journal of AOAC International showcase his academic influence and contributions to pharmaceutical quality control and safety. Additionally, Dr. Çalışkan has played a crucial role in securing and maintaining laboratory accreditations, further evidencing his standing in the professional R&D community. With continued recognition through publications, cross-functional leadership roles, and innovation in analytical techniques, it is evident that he is well-positioned for formal accolades in both industrial and academic circles. Nomination for a Best Researcher Award would be a fitting acknowledgment of his significant impact on pharmaceutical research and method validation at both national and international levels.
Conclusion
Dr. Cem Çalışkan represents a compelling candidate for the Best Researcher Award, bringing together scientific rigor, innovative thinking, and impactful leadership in the pharmaceutical sector. His multi-tiered education, from chemistry through analytical science to business management, empowers him to operate effectively at the intersection of research, industry, and regulation. His extensive experience with analytical method development, impurity profiling, and compliance documentation, along with his proactive approach to laboratory innovation, positions him as a distinguished researcher. His publication record reinforces his scientific credibility, while his managerial roles highlight his ability to lead R&D initiatives with strategic foresight. What sets Dr. Çalışkan apart is not only his technical excellence but also his drive to elevate pharmaceutical research standards in Turkey and beyond. As the industry faces increasing regulatory scrutiny and demands for innovation, his skill set is more relevant than ever. Recognizing his achievements through a Best Researcher Award would honor a career dedicated to advancing analytical science and fostering pharmaceutical innovation, while inspiring emerging researchers to pursue excellence in both academia and industry.
Publications Top Notes
1. Comparison of permeability of topical Cream drug through polymer synthetic membranes of different structures using Franz Cell diffusion test
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Authors: Cihan Torlak, Müge Güleli, Şevki Kızılok, Remziye Azra Kartop, et al.
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Year: 2024
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Journal: Journal of Dispersion Science and Technology
2. Evaluation of a Novel LC‑MS/MS Based Analytical Method for the Risk Assessment of Nitrosamines in Pharmaceutical Products and Packaging Materials
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Authors: Remziye Azra Kartop, Cihan Torlak, et al. (study led by Kartop and colleagues)
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Year: 2024
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Journal: Journal of Pharmaceutical Sciences
3. Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC‑MS/MS