Rasul Sadeghnejad
Associate Principal Scientist Bioanalytical R & d @Rocket Pharmaceuticals
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WORK HISTORY
Associate Principal Scientist Bioanalytical R & d @Rocket Pharmaceuticals
Cranbury, NJ, US
Partner with group leadership and CMC stakeholders to define and execute analytical and control strategies, aligning assay development, qualification, and stability testing with CQAs and regulatory expectations.• Drive resolution of complex, high-risk analytical challenges, including regulatory agency comments, by identifying critical assays, prioritizing execution plans, and directing parallel supporting studies to meet submission timelines.• Lead development and lifecycle management of cell-based potency assays to define mechanism of action and functional activity, supporting vector release, characterization, and IND-enabling studies.• Design and qualify process- and impurity-related residual assays (e.g, host cell DNA, cytokines) using ELISA, ddPCR, and CE to strengthen analytical control strategies.• Apply analytical methodologies (SEC-MALS, CE, ELISA, ddPCR, MS, AUC, molecular techniques) to establish robust characterization strategies and reference standards.• Design and execute QbD- and DoE-driven studies to assess stability, robustness, and support specification setting for clinical-stage products.• Lead and matrix-manage multiple analytical teams (2–3 scientists per team), setting priorities, reviewing data, and making final technical decisions in response to QC feedback and program risk.• Manage multiple parallel workstreams by balancing assay development, qualification, and validation activities while authoring and reviewing protocols, worksheets, and technical reports.• Author and review CMC technical reports and regulatory documentation supporting IND submissions and agency interactions.
EDUCATION
Lehigh University
Doctor of Philosophy - PhD, Chemical and Biomolecular Engineering
Amirkabir University of Technology - Tehran Polytechnic
Master's degree, Chemical Engineering
Amirkabir University of Technology - Tehran Polytechnic
Bachelor's degree, Chemical Engineering
ABOUT RASUL SADEGHNEJAD
Principal-level Analytical Development scientist with 7+ years of experience advancing biologics and advanced therapeutic programs through assay strategy, analytical characterization, and CMC execution. Demonstrated record of delivering high-impact, data-driven solutions to complex scientific and regulatory challenges under aggressive timelines. Deep expertise in cell-based potency assays, protein and viral vector characterization, and process- and impurity-related residual assays. Strong practitioner of CQAs, and DoE principles, with a collaborative leadership style and a focus on regulatory-ready documentation supporting IND and BLA submissions.
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