Caleb Small

Caleb Small Email and Phone Number

Senior Director of CMC QA @ Ultragenyx
South San Francisco, CA, US
Caleb Small's Location
South San Francisco, California, United States, United States
Caleb Small's Contact Details

Caleb Small personal email

About Caleb Small

- Over 16 years of biotech/pharma experience in Mfg, MQA, and QA for QC for clinical and commercial Drug Substance, Drug Product, and Label/Pack, including combination products and Gene therapies.- 16 years in leadership positions, managing between 9 - 65 direct/indirect reports.- Developed 2 different Quality Systems for the management of non-conformances, change controls, CAPAs and product complaints.- Oversight of and collaboration with CMOs in both Mfg and Quality roles.- Primary presenter to Health Authorities during audits for several Quality Systems.- In depth knowledge of SAP, Veeva, and Trackwise.- Management of budget and labor forecasts for entire departments in Mfg and MQA.

Caleb Small's Current Company Details
Ultragenyx

Ultragenyx

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Senior Director of CMC QA
South San Francisco, CA, US
Caleb Small Work Experience Details
  • Ultragenyx
    Senior Director Of Cmc Qa
    Ultragenyx
    South San Francisco, Ca, Us
  • Astellas Gene Therapies
    Site Head Of Quality
    Astellas Gene Therapies Mar 2024 - Present
    San Francisco, Ca, Us
  • Astellas Gene Therapies
    Associate Director Quality Assurance
    Astellas Gene Therapies May 2023 - Mar 2024
    San Francisco, Ca, Us
  • Astellas Gene Therapies
    Senior Quality Assurance Manager
    Astellas Gene Therapies Apr 2021 - May 2023
    San Francisco, Ca, Us
  • Genentech
    Qa Manager Capas, Complaints, Deviations
    Genentech Mar 2018 - Apr 2021
    South San Francisco, California, Us
  • Genentech
    Quality Assurance Supervisor
    Genentech Jul 2013 - Mar 2018
    South San Francisco, California, Us
  • Genentech
    Commecial Inspection Supervisor
    Genentech Jan 2011 - Jul 2013
    South San Francisco, California, Us
  • Genentech
    Cho Purification Supervisor
    Genentech Apr 2010 - Jan 2011
    South San Francisco, California, Us
  • Genentech
    Supervisor Marketed Packaging
    Genentech Dec 2009 - Apr 2010
    South San Francisco, California, Us
  • Genentech
    Lead Operator
    Genentech Aug 2009 - Dec 2009
    South San Francisco, California, Us
  • Genentech
    Marketed Pack Operator
    Genentech Aug 2008 - Aug 2009
    South San Francisco, California, Us

Caleb Small Skills

Biotechnology Gmp Purification Fda Validation Aseptic Processing Capa Biopharmaceuticals Lims 21 Cfr Part 11 Change Control Sop

Caleb Small Education Details

  • Occidental College
    Occidental College
    Biochemistry
  • Eastern Arizona College
    Eastern Arizona College
    General Studies

Frequently Asked Questions about Caleb Small

What company does Caleb Small work for?

Caleb Small works for Ultragenyx

What is Caleb Small's role at the current company?

Caleb Small's current role is Senior Director of CMC QA.

What is Caleb Small's email address?

Caleb Small's email address is sm****@****ene.com

What schools did Caleb Small attend?

Caleb Small attended Occidental College, Eastern Arizona College.

What skills is Caleb Small known for?

Caleb Small has skills like Biotechnology, Gmp, Purification, Fda, Validation, Aseptic Processing, Capa, Biopharmaceuticals, Lims, 21 Cfr Part 11, Change Control, Sop.

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