Senior Associate Director, Validation Strategy

Scorpion Therapeutics; Bedford (MA); On-site; USD 190,000 - 230,000; Full time

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

Process Validation

cGMP

FDA/ICH Standards

Validation Lifecycle

Cold Chain Shipping

Packaging Validation

Regulatory Inspection Support

Leadership

Pharma Manufacturing

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related

Job description

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