Sivakumar Gajjeraman Email & Phone Number

Canada

United States

Winnipeg, Canada | San Diego Usa

As the Analytical CMC Lead, spearhead the development and implementation of a comprehensive analytical method strategy, collaborating closely with cross-functional teams to ensure seamless coordination of analytical activities crucial for the commercialization of both active pharmaceutical ingredients and drug products.Key Responsibilities:• Act as the primary author for the CMC/BLA/IND sections of regulatory submissions, meticulously detailing analytical test methods along with validation documentation to ensure alignment with FDA guidelines and regulatory requirements.• Provide extensive technical support and oversee method transfer activities to Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs), particularly in the context of vaccine development and manufacturing operations.• Efficiently manage and coordinate deliverables from CDMOs, maintaining a robust oversight of ongoing programs such as Ebanga, a licensed drug product for Ebola viral diseases, to ensure timely and compliant execution.• Led internal teams in the development and execution of analytical methods tailored to address pertinent Post-Marketing Commitments (PMC) and Post-Marketing Requirements (PMR) for the Ebanga CMC areas, notably including the establishment and validation of in-vitro virus neutralization assay and ADCC activity assay.• Provide invaluable operational expertise in CMC areas, demonstrating proficiency in executing technology transfers and overseeing routine operations within a cGMP-compliant environment.• Successfully established and validated a panel of analytical methods for Sudan mAb TOX lot, overseeing seamless method transfer to CDMOs for Process Performance Qualification (PPQ) lots and subsequent release for clinical trials.

San Diego, Ca, Usa | Winnipeg, Manitoba, Canada

• Managed a high-performing team of scientists on multiple projects ((FluB, WEVEE VLPs, Pan Ebola mAbs, and Chikungunya VLPs) advancing the design, development, execution, and validation of analytical methods for early and late-stage bulk drug substances and drug products.• Steered the development, execution, and validation of analytical methods to confirm the quality of final antibody therapeutic drug substances and drug products, adhering to ICH and FDA guidelines.• Planned and delivered validated compendial and non-compendial analytical methods to advance projects to the clinical stage.• Partnered with cross-functional teams to write study or technical reports, SOPs, CoA, and protocols, supporting investigation of nonconformances and analytical sections of IND and BLA documents.• Swiftly identified and evaluated new targets/candidates as a member of ‘The target Selection Committee.• Led a team of scientists in advancing pipeline products, providing technical and strategic solutions throughout product life cycle management.• Designed strategies for antigen delivery and presentation in equine for developing equine hyperimmune antibodies targeting COVID-19/SARS-Cov2, CCHF, and Ebola viral diseases.• Developed a panel of analytical methods and bioassays for pre-clinical and clinical trials, overseeing completion and delivery of reagents for analysis.• Completed proof-of-concept programs to develop and evaluate broad-spectrum βCoV therapeutic protein products.• Established new platform assays to screen human samples (around 6K) for SARS-CoV2 and Lyme, evaluating and suggesting new technologies for business development.• Built and maintained research collaborations and networks, mentoring junior scientists and interns.

Bedford, Texas 76022

Key Accomplishments:• Provided strategic leadership in a dynamic environment, guiding technical staff and driving solutions-focused resolutions to achieve organizational objectives.• Orchestrated the coordination of multiple projects within teams, ensuring strict adherence to Good Laboratory Practices (GLP) standards.• Spearheaded initiatives resulting in the publication of 5 research articles and successfully secured two SBIR grants totaling $500K, along with one NIH RO1 industrial grant worth $1.1 million annually.• Directed the development of three projects, transitioning them from proof of concept to the clinical stage, particularly focusing on optogenetics-based vision restoration therapy.• Conducted comprehensive in-vitro and in-vivo analytical and cell-based characterization studies for the evaluation of three therapeutic transmembrane protein molecules, facilitating informed decision-making in the development process.• Pioneered a novel Nano-enhanced optical delivery technique for in-vivo delivery of therapeutic molecules, optimizing delivery into pre-clinical cell culture models and animal models while strictly adhering to GLP regulations.

Providence, Rhode Island

Skills: Protein Science, Molecular biology, X-Ray Crystallography, Cloning, Recombinant protein expression, purification of proteins, Analytical Methods and Characterization (SDS-PAGE, icIEF, Western, Identity, HPLC-SEC, HPLC based Ion-exchange chromatography etc., Mentoring and Protect Management

Evanston, Illinois, United States

Skills: Protein Science, Molecular biology, X-Ray Crystallography, Cloning, Recombinant protein expression, purification of proteins, Analytical Methods and Characterization (SDS-PAGE, icIEF, Western, Identity, HPLC-SEC, RP-HPLC, HPLC based Ion-exchange chromatography etc., Mentoring and Project Management

Winnipeg, Manitoba, Canada

Skills: Protein Science, Molecular biology, X-Ray Crystallography, Cloning, Recombinant protein expression, purification of proteins, Analytical Methods and Characterization (SDS-PAGE, icIEF, Western, Identity, HPLC-SEC, HPLC based Ion-exchange chromatography etc., Mentoring and Project Management

Post Doctoral Studies

Post Doctoral Studies

Doctor Of Philosophy - Phd