Sivakumar Gajjeraman Email & Phone Number

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.
• 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.
• 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.
• 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.
• Provide invaluable operational expertise in CMC areas, demonstrating proficiency in executing technology transfers and overseeing routine operations within a cGMP-compliant environment.

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.
• 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.

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.

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