Director, Manufacturing Process & Technical Quality - CGT

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics in Boston seeks a Director of Manufacturing Process & Technical Quality to oversee QA and compliance for Cell & Gene Therapies from development to post-approval. You will translate the quality strategy into operational plans and lead lifecycle quality activities.

This role requires deep GXP knowledge, experience across clinical to commercial stages, and strong leadership to coordinate with Development, Manufacturing, Regulatory, and external partners, including support for

Qualifications

• Bachelor's degree in life sciences, biotech, or engineering.
• 10+ years in biotech/pharma quality, manufacturing, or technical operations.
• At least 3 years of leadership experience.
• Deep knowledge of global GXP regulations and cell/gene therapy tech (e.g., AAV).
• Experience across clinical to commercial product life cycles.
• Strong leadership, communication, and influencing skills.

Responsibilities

• Translate quality strategy into operational plans to ensure GxP compliance.
• Lead lifecycle quality activities from development through post-approval.
• Ensure adherence to global GXP regulations and regulatory standards.
• Support manufacturing readiness and risk management.
• Collaborate cross-functionally with Development, Manufacturing, Regulatory, and external partners.
• Support regulatory inspections and submissions.

Skills

Leadership

Communication

Influence

Cross-functional Collaboration

Education

Bachelor's degree in life sciences or engineering

Job description

Role: Director of Manufacturing Process & Technical Quality

overseeing quality assurance and compliance for Cell & Genetic Therapies from development to post-approval. Responsibilities include translating quality strategy into operational plans, ensuring adherence to GxP and regulatory standards, leading product lifecycle quality activities, supporting manufacturing readiness, and managing risk and compliance. The role involves cross-functional collaboration with Development, Manufacturing, Regulatory, and external partners, and supports regulatory inspections and submissions.

Qualifications: Bachelor's in life sciences, biotech, or engineering; 10+ years in biotech/pharma quality, manufacturing, or technical operations; at least 3 years of leadership experience; deep knowledge of global GXP regulations, cell and gene therapy technologies (e.g., AAV, aseptic processing); experience across clinical to commercial stages; strong leadership, communication, and influence skills.

High-value specifics include focus on Cell & Gene Therapy, biologics, regulatory submission support, and lifecycle quality oversight.

Work setup is hybrid or on-site with up to 25% travel.