Associate Director, Validation
Scorpion Therapeutics
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Job summary
Scorpion Therapeutics is seeking an Associate Director of Validation to lead validation strategies across process performance, lifecycle, shipping, and packaging validation in ophthalmic biopharma manufacturing. The role requires developing and executing validation plans, overseeing PPQ campaigns, and acting as SME during inspections.
Candidates should have a Bachelor's in Engineering, Pharmaceutical Sciences, Chemistry, or related field with 12+ years in pharma/biotech manufacturing and deep
Qualifications
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related field.
- 12+ years of pharma/biotech manufacturing with strong validation expertise.
- Strong knowledge of Process Validation, cGMP, FDA/ICH standards.
Responsibilities
- Develop and execute validation plans, protocols, and risk assessments.
- Oversee PPQ campaigns, continuous process verification, and cold chain shipping validation.
- Serve as SME during inspections and audits.
- Manage validation resources and drive continuous improvement.
Skills
Education
Job description
Associate Director of Validation leading validation strategies for process performance, lifecycle, shipping, and packaging validation in ophthalmic biopharma manufacturing.
develop and execute validation plans, protocols, and risk assessments; oversee PPQ campaigns, continuous process verification, and cold chain shipping validation; serve as SME during inspections and audits; manage validation resources and drive continuous improvement.
Bachelor's in Engineering, Pharmaceutical Sciences, Chemistry, or related; 12+ years in pharma/biotech manufacturing with significant validation expertise; strong knowledge of Process Validation, cGMP, FDA/ICH standards, and validation lifecycle principles; experience in Cold Chain Shipping and Packaging Validation preferred.
ophthalmic drug/device manufacturing, process validation, lifecycle validation, cold chain shipping, cGMP compliance, regulatory inspection support.
not specified; senior leadership role.
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