Liton R. — CEO

I am a seasoned leader in the biopharmaceutical industry with over 15 years of experience that spans the entire drug development lifecycle, from early development through commercialization. My career has been marked by a progressive increase in responsibility, demonstrating my ability to manage complex, cross-functional, and global projects effectively. I thrive in roles that require strategic thinking, scientific and technical leadership, and the ability to manage multiple priorities. My expertise lies in analytical development, process validation, and technology implementation, all underpinned by a deep understanding of regulatory requirements. Key Areas of Expertise: • Leadership & Program Management: Proven ability to lead teams, manage programs, and collaborate globally. Led oncology and immunology/inflammation (I&I) programs across multiple therapeutic modalities, in both startup environments and established companies. • Analytical Science & Process Validation: In-depth experience in the characterization, method development, phase-appropriate qualification and validation, CQA assessment, integrated control strategy, RS qualification of both biologics and synthetic drugs. • Radiopharmaceuticals: Specialized in the development and characterization of radiopharmaceuticals. • Drug Development: Extensive experience in the development and validation of solid oral dosage forms, semi-solids, and sterile drug products. • Regulatory Technology: Skilled in cloud technology development within the regulatory domain, ensuring compliance and efficiency. • Regulatory Submissions: Expert in authoring CMC sections for IND, NDA, BLA, ANDA, CBE-30, PAS, and 505(b)(2) submissions, and in preparing responses to Information Requests (IRs) and Complete Response Letters (CRLs). • Compliance & Quality: Strong adherence to GLP, cGMP, USP/NF, Ph. Eur., JP, ICH, and FDA guidelines. • Digital Enablement: Driving digital transformation across laboratory operations, quality systems, supplier management, clinical operation, and biopharmaceutical manufacturing to enhance agility, data integrity, and operational excellence.

Stackforce AI infers this person is a seasoned leader in the biopharmaceutical industry with expertise in drug development and regulatory compliance.

Location: Los Angeles, California, United States

Experience: 15 yrs 3 mos