Steven Erb

About Steven Erb

I am an accomplished, innovative, and resourceful leader in CMC with experience in cell therapy, virus vaccines, analytical method development, regulatory affairs, tech transfer, drug product formulation, and drug product manufacture in small biotech and big pharma environments. I have extensive experience managing outsourced projects and acting as liaison between internal groups and external CDMOs.My industry experience in Cell Therapy and Vaccines has made me highly adaptable to different roles within an organization and has cultivated the line of sight and strategic thought required to effectively navigate a product from early to pivotal phases of development. I have a strong ability to lead, design, and deliver complex projects to successful completion under aggressive timelines and to effectively interpret and communicate technical data and scientific concepts to varied stakeholders. I am passionate about making contributions to the improvement of public health with a patient first mindset. I am collaborative by nature and find great joy in leading and being a part of high functioning teams while also effectively navigating cross-functionally in matrixed working environments.Given my CMC experience, unique perspective on problem solving, and passion for improving human health, I created my own Consulting Service - Crown Point Biotech Consulting LLC (please see my dedicated company page link here to support companies in their CMC journey to bring life changing therapies to patients. Don\'t hesitate to reach out to see how I can help your Team today!

Experience

1. Founder and Principal Consultant

   Crown Point Biotech Consulting Llc

   Jul 2024 — Present · Fort Collins, CO, US

   Supporting your Analytical Development, Quality Control, CDMO management, and Regulatory needs in ATMP and virus vaccine CMC development. Services and Competencies include but are not limited to:• Extensive experience in leading drug product and in-process analytical development programs from method identification, optimization, and qualification using risk-based approaches to implementation in quality control environments.• Quality Control leadership for in-process and drug product release and characterization testing performing quality document audits, review of deviations, CAPAs, and OOS/OOT investigations, establishing control strategies with the proven ability to drive product release timelines. • Significant experience managing analytical programs at CDMOs including defining outsourcing strategies and managing analytical development and qualification activities at domestic and international external partners.• Subject Matter Expert for Technology Transfer of comprehensive analytical control programs.• Development of Regulatory Affairs strategies for compliant product development and authorship of high-quality CMC dossier content for INTERACT, pIND briefing books, IND, IMPD, application amendments, agency responses, and annual reports.• Design of drug product comparability studies to support transitions between process and site changes.• Stability Study program management including study design, protocol and report authorship, and data analysis. • Drug product formulation development expertise.• Interim program leadership for companies needing to fill resource gaps or who are experiencing leadership transitions.• Exceptional cross-functional and interpersonal communication skills providing seamless integration into your ways of working.Please contact me at s••••••••@crownpointbiotech.com or visit my company page at to discuss how I can help you bring your product to patients today.

Education

• Millersville University of Pennsylvania

  Bachelor of Science (BS), Molecular Biology

  1999 — 2003

• Colorado State University

  Doctor of Philosophy (Ph.D.), Virology

  2005 — 2011

• Emerging Infectious Disease Training Fellowship

  Class 9, CDC/Influenza Branch/Virology, Immunology, and Pathology

  2003 — 2004

Skills

• Microbiology
• Immunology
• Assay Development
• Design of Experiments
• Tissue Culture
• Formulation
• Elisa
• Vaccines
• Virology
• Molecular Biology
• Technology Transfer
• Pcr
• Data Analysis
• Gxp
• Biotechnology
• Research and Development (R&D)
• Cell Culture
• Lifesciences
• Lyophilization
• Western Blotting
• Infectious Diseases
• In Vitro
• Change Control