Tatiana Golovina is a distinguished Process and Analytical Leader with over two decades of multifaceted experience in cell therapy, encompassing process development, analytical innovation, scale-up, and regulatory documentation. Her career trajectory exemplifies technical mastery combined with visionary leadership, making her a highly respected figure in the biotechnology and pharmaceutical industries.
Until recently, as Senior Vice President of Development at BlueWhale Bio, Inc., Tatiana has played a pivotal role in establishing and scaling the organization’s Process Development, Analytical Development, and Cell Biology laboratories. In just 12 months, she grew the team from two associates to 20, building a robust infrastructure to drive innovative product development and functional testing. Her leadership ensured a seamless technical transfer of manufacturing processes from the University of Pennsylvania to BlueWhale Bio.
Prior to BlueWhale Bio, Tatiana held progressively senior roles at WuXi Advanced Therapies, culminating as Executive Director of Cell Therapy Process and Technology Development. She spearheaded the development of end-to-end process development (PD) to manufacturing support and technology (MS&T) functionality, notably accelerating IND submissions for clients. Tatiana’s leadership was instrumental in revenue growth, as she secured new cell therapy clients and retained existing ones through cutting-edge CART and TIL platform validation and optimization.
Tatiana’s tenure at Novartis Pharmaceuticals further highlights her technical acumen and strategic contributions. As a Fellow in Cell and Gene Therapy, she led critical process improvements for Kymriah, the first FDA-approved CAR-T cell therapy. Her innovations resulted in two patents and enhanced the manufacturing protocol, which was crucial for clinical success and regulatory submissions.
Her earlier roles include leading assay development at Fraunhofer Center for Molecular Biotechnology, where she managed high-impact global projects funded by the Gates Foundation and DARPA. At the University of Pennsylvania, she advanced adoptive T cell therapy research, pioneering methods for isolating and expanding human T regulatory cells.
Tatiana’s expertise extends to strategic manufacturing assessments, technical transfers to CDMOs, process optimization, and quality control strategies. Her leadership is complemented by her ability to build high-performing teams, streamline processes, and foster innovation in highly regulated environments.
She holds a Ph.D. in Bioorganic Chemistry from the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry and a B.S. in Biology from Lomonosov Moscow State University. Tatiana’s academic excellence is reflected in her numerous peer-reviewed publications and patents, underscoring her role as a thought leader in cell and gene therapy.
Her professional certifications, including Novartis’s M1 Leading in the Frontline and a Clinical Research Certificate from the University of Pennsylvania, further solidify her credentials. Recognized with accolades such as the CART IGT Business Excellence Award, Tatiana’s dedication to advancing cell therapy continues to drive transformative outcomes in the biotech industry.
Tatiana Golovina stands as a paragon of technical expertise and leadership in cell therapy, continually shaping the future of therapeutic innovation and patient care.
Character
Tatiana Golovina demonstrates unwavering integrity, resilience, and a results-driven mindset, consistently fostering innovation and collaboration in high-pressure environments.
Knowledge
With extensive expertise spanning cell therapy process development, analytical innovation, and regulatory compliance, Tatiana possesses deep technical and scientific proficiency to drive advancements in biotechnology.
Strategic
Tatiana excels at devising and executing comprehensive strategies, from technical transfers to process optimization, enabling organizations to accelerate timelines, enhance quality, and achieve business growth.
Communication
A skilled communicator, Tatiana effectively conveys complex technical concepts to diverse stakeholders, inspiring teams and fostering productive relationships across multidisciplinary and global teams.
