Jacob Justus

About Jacob Justus

I am experienced in developing and deploying successful and robust alliance and program management processes and best practices in pre-clinical, clinical, and commercial phase biopharma and biotech companies with management of dozens of partnerships, alliances, and clinical programs in the small molecule, biologics, and cell and gene therapy spaces. I have held leadership roles which included development and management of >$20 million budget for pre-clinical and clinical programs for small molecule and cell and gene therapy programs. My cross-functional collaborative engagements have led to successful filing of multiple IND and CTA applications with US FDA, Health Canada, and EU. Further, I have fostered and grown collaborations and partnerships which have generated over $20 million. I am a former member of the Alliance for Regenerative Medicine Committee (ARM) and am knowledgeable with FDA Title 21 CFR Part 211, 610, and 1271; IND, NDA, CTA, and BLA filings; EMA Regulations; Health Canada (HC) Regulations; ISO 13485 Standards; and ICH Guidelines. I have held a professional alliance management certification (CA-AM) from ASAP.Specialized in: Regenerative Medicine, Cell and Gene Therapy, Small Molecules, Alliance Management, Business Development, Program & Portfolio Management, Corporate Strategy, Financial Forecasting, Clinical Trial Operations, Metrics & Reporting, Data Governance, cGxP, CMC, CFR, ICH, FDA Regulations, Compliance, Quality, Regulatory, Data Management, Combination Device, Platform Technology, IND & CTA Enabling Technologies, CRISPR, Gene Editing, AI (artificial intelligence) and ML (machine learning) approaches to Drug Discovery and Development, Analytical Chemistry

Experience

1. Director (Head), Program Management

   Autobahn Therapeutics, Inc

   Dec 2025 — Present · San Diego, CA, US

Education

• San Bernardino Valley College

  Associate of Science (AS) - transferred, Computer and Electrical Engineering

• Keck Graduate Institute

  Master of Business & Bioscience (MBS) - Professional Science Masters (PSM), Pharmaceutical Discovery & Development, and Bioprocessing

• California State University-San Bernardino

  Bachelor of Science (BS), Bioinformatics (Computer Science & Engineering) with Biology minor

Skills

• Pharmaceutical Industry
• Dna Sequencing
• Life Sciences
• Microsoft Office
• Phylogenetic Modeling
• Management
• Business Planning
• Access
• Genetics
• Sql
• Css
• Pharmaceutical Development and Discovery
• Business Development
• Regulatory Affairs
• Lifesciences
• Computational Biology
• Consulting
• Process Science
• Biostatistics
• Bioprocessing
• Molecular Biology
• Biosimilars
• Superpro Designer
• Corporate Finance
• Biopharmaceuticals
• Cell Culture
• Bioinformatics
• Biochemistry
• Matlab
• Python
• Cmc
• Cgxp
• Pcr
• Project Management
• Network Administration
• Research
• Ngs
• Genomics
• Mysql
• Quality Assurance