Nandakumar Sundaramoorthy

• Leading client discussions, strategizing approaches to execute parallel projects to accelerate the portfolio deliverables.
• Translating client RFPs/RFIs into detailed technical work scopes, timelines, resource plans, and cost estimates.
• Contributing to proposal defense meetings to clarify scientific and operational approaches.
• Spearheading CMC packages for mAbs, multispecific antibody, peptides, biosimilars programs as per client needs.
• Implementing QbD approaches during cell line development by improving the quality attributes, to fast track IND submission for Biologics.
• Directing therapeutic peptide programs for ANDA submissions (FDA, ANVISA, Health Canada).
• Overseeing the development, transfer and validation of critical analytical methods for product characterization, biosimilarity, sameness, release and stability studies.
• Contributing to clone development, developability, process development in early stage product development.
• Monitoring key performance indicators to track the success of process improvement initiatives.
• Providing leadership and technical guidance to process and analytical scientists.
• Striving continuous improvement by leveraging emerging technologies and tools to streamline processes.
• Contributing to marketing materials, capability presentations, and technical brochures to enhance business visibility.

Responsibilities aligned with current role

• Collaborated with internal and external stakeholders for the development of new products from conception to market launch.
• Collaborated with cross-functional teams to translate client RFPs/RFIs into well-defined technical deliverables, schedules, and costed project plans.
• Contributed directly to the quality module and successful progression for three Biologics program.
• Led technical operations for the analytical and formulation development.
• Oversaw the development, qualification, characterization and validation of analytical methods for product characterization, release, and stability.
• Managed technology transfer processes both internally and externally.
• Collaborated with the regulatory team in addressing complex CMC queries during the agency interaction.
• Oversaw scientific and technical document reviews.
• Oversaw capital and operational expenditures, workforce planning, and outsourcing operations to ensure optimal departmental performance and cost efficiency.
• Tracked proposal metrics, conversion rates, and client feedback for continuous improvement.

• Led a team of scientists for Biologics development programs from Gene to GMP.
• Accomplished all project deliverables, comply with regulatory standards and guidelines, reviewing documentation for EMA and ANVISA submissions.
• Oversaw the development, qualification, and validation of analytical methods for product characterization, release, and stability.
• Oversaw analytical domain for technology transfer, process optimization & characterization, and scale-up activities for biologics product development.
• Championed the adoption of advanced technologies (e.g., LC-MS, CE-MS, SPR, multi-attribute methods) for higher-order structural characterization and comparability assessments.
• Ensured robust analytical control strategies were established based on QbD principles and aligned with regulatory expectations (ICH Q6B, Q14).
• Served as the company’s representative at key conferences and professional meetings, effectively communicating ongoing research and development activities to external stakeholders.
• Managed departmental budgets, including capex, opex, manpower, and outsourcing activities.

• Led technicians by designing and implementing preclinical and clinical studies.
• Directed comprehensive screening studies of vaccine candidates to identify effective immunogens against virulent Staphylococcus aureus and Pseudomonas aeruginosa strains.
• Drove research collaborations between Functional Genomics and Immunology & Global Health and vaccinology, Baltimore.
• Drove research collaborations between Functional Genomics and Immunology & Clinical studies, University of Ghent, Belgium.
• Handled design, development, and optimization of Luminex-based multiplex immunoassays for qualitative and quantitative analysis of biomarkers, cytokines, and antibodies.
• Customized Bioassays to meet project-specific requirements in vaccine, biologics, or immunogenicity studies.
• Authored and critically reviewed research outcomes and manuscripts intended for publication in high-impact scientific journals.
• Evaluated emerging high-throughput analytical platforms (e.g., MSD, SIMOA, Ella) for enhanced biomarker detection and quantitation.