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Henry WolfeHW

Henry Wolfe

Peptides & Biologics Development

£1,200/day
Philadelphia, US
15+ years

Average response time: 1 hour

About Henry

Highly experienced in peptide (40 years) and Biologics (30 years) drug development. Focused on the development and validation of Drug Substance and Drug Product processes and formulations in compliance with EMA, FDA and ICH guidelines. Successfully developed and and validated approved products, processes and formulations for the US, EU and global markets.
  • English

    Native or bilingual

Remote only
Primarily works remotely

Experience

  • Ironwood Pharmaceuticals
    Head Product Development (Fractional contractor)
    BIOTECH
    November 2025 - April 2026 (5 months)
    Boston, United States
    • Lead all CMC activities for phase 3 peptide program
    • Manufactured peptide drug product clinical supplies for a phase 3 program.
    • Manage global supply chain function for 45 sites in 17 countries
    • Technical cosultant to drug substance process development
    Peptide Process Development Clinical supply manufacturing
  • Centessa Pharmaceuticals
    Senior Vice President Biologics & Supply Chain
    BIOTECH
    November 2022 - December 2025 (3 years and 1 month)
    Boston, United States
    • Lead CMC activities for all Biologics programs
    • Biologics development for four programs
    • drug substance process development, characterization and validation
    • Formulation development, characterization and validation
    • cGMP manufacturing for research through phase 3 clinical supply
    • Clinical supply for 72 sites in 20 countries
    Formulation Development Biologics Process Development Process validation Clinical manufacturing
  • Endo Pharma
    Vice President, Biologics R&D
    BIOTECH
    June 2019 - November 2022 (3 years and 5 months)
    Horsham, United States
    • Led peptide process & formulation developments for teduglutide & lanreotide
    •BLA approval for Qwo® (collagenase clostridium histolyticum aaes)
    • Post-approval process optimization of cell growth parameters yielded
    a 50% reduction in cost-of-goods.
    • Lead all technical aspects of design, facility/equipment IQ/OQ, technology
    transfer, and qualification of agreen field biologics manufacturing facility in India for FDA licensure.

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Education

  • PhD
    Thomas Jefferson University
    2026
    Pharmacology - Structural design of heat stable enterotoxin peptide analogs
  • MS
    Virginia Polytechnic & Sate University
    1983
    Biochemistry

Skill set

Categories

  • Other