Associate Director, Commercial Manufacturing & Packaging

Scorpion Therapeutics

United States

Remote

USD 180,000 - 240,000

Full time

6 days ago
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Job summary

Scorpion Therapeutics seeks an Associate Director of Commercial Manufacturing to oversee global drug product manufacturing and packaging for rare disease therapies. You will manage manufacturing planning, CMO governance, validation, tech transfer, and supply-risk mitigation, ensuring continuous, compliant supply.

Remote work with face-to-face collaboration in San Diego and travel up to 10% are expected. The role requires a Bachelor's in Engineering and 8+ years in pharmaceutical manufacturing,

Qualifications

  • 8+ years of leading pharmaceutical manufacturing, with emphasis on process troubleshooting and optimization.
  • Experience with multiple dosage forms, preferably oral solid dosage.
  • Process validation, project management, risk mitigation, and strong communication.

Responsibilities

  • Coordinate manufacturing activities at CMOs and liaise with suppliers to align schedules with sales forecasts.
  • Verify process qualification and support troubleshooting to maintain continuous GMP-compliant operations.
  • Maintain GMP compliance and represent manufacturing in due diligence and regulatory interactions.
  • Author technical reports and contribute to regulatory submissions and audits.
  • Develop and monitor manufacturing plans, risk mitigation strategies, and technology transfer initiatives.
  • Engage in cross-functional collaboration with regulatory, quality, and supply chain teams.
  • Manage cross-site coordination and ensure smooth face-to-face collaboration with San Diego teams while traveling as needed.

Job description

Role

Associate Director of Commercial Manufacturing overseeing global drug product manufacturing and packaging for rare disease therapies. Objectives include ensuring continuous, compliant supply by managing manufacturing planning, CMO governance, validation, technology transfer, and supply-risk mitigation.

Responsibilities
  • coordinating manufacturing activities at CMOs
  • developing schedules based on sales forecasts
  • verifying process qualification
  • supporting troubleshooting
  • maintaining GMP compliance
  • representing manufacturing in due diligence and regulatory interactions
  • authoring technical reports
Qualifications
  • Bachelor's in Process/Chemical Engineering or related field
  • 8+ years leading pharmaceutical manufacturing, including process troubleshooting and optimization
  • experience with multiple dosage forms, preferably oral solid dosage
  • process validation, project management, risk mitigation, and strong communication
Preferences
  • familiarity with US/EU GMP standards
  • complex project management
  • international travel (up to 10%)
Sector specifics
  • biologic or small molecule manufacturing for rare disease therapies
  • involvement in regulatory submissions and audits
Work setup

remote with face-to-face collaboration in San Diego; travel required.

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