CAR-T Manufacturing Investigator/Technical Writer

Job Title: CAR-T Manufacturing Investigator / Technical Writer
Location: Morris Plains, NJ 07950
Duration: 12 Months (W2 Contract)

Key Responsibilities:

• Write and manage high-quality, technically sound investigations for manufacturing deviations, including OOS (Out of Specification) and human error events.
• Apply root cause analysis methodologies to determine contributing factors and document findings effectively.
• Draft and implement CAPAs (Corrective and Preventive Actions) with a focus on reducing recurrence of routine issues.
• Collaborate with manufacturing, quality, and technical teams to gather required information and close investigations efficiently.
• Support inspection readiness activities ahead of a potential FDA visit by January.

Preferred Experience & Skills:

• Strong background in CAR-T or Cell & Gene Therapy manufacturing investigations is essential.
• Experience with Carvykti is a strong plus but not required.
• Solid understanding of GMP regulations and FDA compliance expectations.
• Familiarity with typical deviation types (technical/OOS and human error-related) and investigation tools such as 5 Whys, Fishbone, etc.
• Proficient in writing clear, concise, and compliant technical documentation.
• CAPA development and implementation experience.

Job Type: Contract

Work Location: On the road