Associate Director, Raw Materials MSAT & Lifecycle Strategy

ProKidney Corp.; White Settlement (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney Corp. seeks a seasoned Associate Director, Raw Materials Lead to establish and lead the technical strategy for raw materials used in GMP manufacturing.

You will translate CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier requirements, and ongoing performance monitoring. This role supports BLA readiness, process validation, commercial launch prep, and pre-license inspection activities, guiding cross-functional teams to ensure

Qualifications

• Bachelor's degree in Biological Sciences or related field is required.
• Advanced degree is preferred.
• Strong knowledge of CMC and biologics regulatory expectations.

Responsibilities

• Develop and implement strategic frameworks for raw material lifecycle management.
• Lead cross-functional initiatives to define material control strategies.
• Partner with QA and Supply Chain on supplier qualification and monitoring.
• Establish and manage extractables/leachables program using risk-based methods.
• Oversee cGMP visual inspection program including sampling, training, escalation, and trend review.
• Define critical material attributes linked to process performance.
• Act as subject matter expert on raw material science within CMC teams.
• Conduct risk assessments and supplier evaluations; manage post-approval changes.
• Collaborate on regulatory submissions and health authority interactions.

Skills

CMC knowledge

Risk-based management

Cross-functional leadership

Regulatory readiness

Education

Bachelor's degree in Biological Sciences

Advanced degree preferred

Job description

ProKidney Corp. seeks a seasoned Associate Director, Raw Materials Lead to establish and lead the technical strategy for raw materials used in GMP manufacturing.

You will translate CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier requirements, and ongoing performance monitoring. This role supports BLA readiness, process validation, commercial launch prep, and pre-license inspection activities, guiding cross-functional teams to ensure