Asim Siddiqui

A seasoned research scientist with a proven track record of success in bioanalysis, ADME, and clinical pharmacology within regulated environments. With expertise in bioanalytical method development and validation across various platforms, including MSD, Gyrolab, and ELISA, I excel in leading teams to deliver high-quality results. My ability to manage externally outsourced projects, coupled with strong communication and teamwork skills honed through collaborations and authorships, positions me as a valuable asset capable of driving scientific excellence and achieving strategic objectives.

PRINCIPAL SCIENTIST II 01/2023 - Present

• Lead internal Novartis team in enabling matrix collaboration on projects requiring method developments and validations for clinical trials’ sample analyses.
• Oversee technology transfer of internally developed PK & ADA assays to external partners and CROs.
• Contribute to projects and workstreams within scientific and early development initiatives.

TEAM LEAD 12/2021 – 01/2023

• Developed and validated immunogenicity assays against gene therapy vectors- AAV6 & AAV8.
• Conceived experiments to implement project strategy that led to “go” or “no go” decisions.
• Supported and trained matrix direct reports and junior collaborators in bioanalytical method development.

SCIENTIST I 05/2020 – 12/2021

• Provided analytical support for biotherapeutic projects, developing and validating immunoassays (PK, ADA, and Biomarker).
• Assessed drug immunogenicity in support of Non-GLP and GLP pharmacology and toxicity.
• Prepared GLP/GCP documentation e.g., SOPs, plans, and reports.

SENIOR SCIENTIST 12/2019 – 05/2020

• Conducted immunogenicity and toxicity analysis of pre-clinical and clinical samples on multiple platforms - ELISA, GYROS, MSD, and Luminex.
• Developed and validated analytical methods for Biomarkers, PK, ADA, and NAb assays.
• Presented work, wrote reports, and trained junior staff.

CLINICAL RESEARCH ASSOCIATE (CRA) 06/2019 – 12/2019

• Provided operational support to clinical studies and start-up activities.
• Reviewed Budgets and contracts, MSA, confidentiality agreements (CDAs), clinical trial contracts.
• Developed and Reviewed Clinical protocols, reports, and Central lab methods.

TRAVELLING AND RELOCATION (from California, USA to United Kingdom) 10/2018 – 06/2019

ASSOCIATE SCIENTIST 12/2017 – 10/2018

• Developed, validated, and conducted Biomarker & cell-based assays for potential pharmacodynamic markers and neutralizing antibodies.
• Analysed bio-analytical samples for clinical samples in support of Non-GLP and GLP pharmacology and toxicology studies.
• Authored Standard Operating Procedures, validated protocols, and reports.

PhD (Interdisciplinary Biochemistry/ Immunology/ Molecular Biology) - AIIMS, New Delhi, India

Master in Science (M.Sc.) in Biochemistry - Department of Biochemistry, AMU University, India

Certificate in “Pharmacology Essentials” – Harvard Medical School Online Education