Associate Director, Raw Materials MSAT

ProKidney•Winston-Salem, NC

About The Position

The Associate Director, Raw Materials Lead is accountable for establishing and leading the technical strategy, governance framework, and lifecycle management program for raw materials used in GMP manufacturing. The role translates CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier technical requirements, and ongoing performance monitoring. This individual will serve as a key technical leader supporting BLA readiness, process validation, commercial launch preparation, and pre-license inspection (PLI) activities.

Requirements

Bachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.
10+ years of experience in biologics or cell and gene therapy (CGT)
Significant experience supporting autologous cell therapy, CGT or other patient-specific manufacturing operations strongly preferred.
Demonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation.
Deep knowledge of CMC processes for biologics, CGT or Cell Therapy platforms, including technology transfer and lifecycle management
Proven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturing
Strong organizational, problem-solving, and communication skills with the ability to influence decisions across teams
Experience with commercial product lifecycle management including post-approval changes and supplier updates
Comprehensive understanding of cGMP requirements and regulatory expectations related to raw materials
Strong executive communication and inspection interaction skills
Ability to influence across Quality, Manufacturing, and Technical Operations
Strategic systems-thinking capability
Strong operational judgment under high-pressure manufacturing conditions
Ability to build a proactive culture around continuous improvement
May lead a team of engineers/scientists
Excellent mentoring and organizational leadership skills
Exhibit TRAC Leadership values

Nice To Haves

Advanced degree preferred.

Responsibilities

Develop and implement strategic frameworks for raw material knowledge transfer and lifecycle management
Lead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturability
Partner with Quality Assurance and Supply Chain to define the technical elements of supplier qualification, supplier monitoring, change notification assessment, and supplier corrective action plans.
Establish and manage the extractable/leachables program using risk based methodologies with external partners
Establish and govern the cGMP visual inspection program, including defect standards, sampling approaches, training requirements, escalation criteria, and trend review.
Define critical material attributes and their linkage to process performance and robustness
Act as the subject matter expert on raw material science within CMC technical teams
Conduct risk assessments, supplier evaluations, and manage post-approval changes related to raw materials
Collaborate on regulatory submissions and health authority interactions regarding material science topics
Ensure timely, science-based root cause analysis and effective CAPA implementation for raw material related deviations and proactive initiatives
Review deviations, change controls, and risk assessments impacting raw material operations, including vendor notifications
Drive continuous improvement initiatives to strengthen robustness of raw material program.
Support strategic planning for commercial manufacturing readiness and network expansion.
Build and lead high-performing raw material team focused on risk mitigation strategies
Develop training programs focused on: Material Qualification, In-coming receipt, inspection and testing, cGMP cleanroom practices
Foster a strong quality culture emphasizing proactive risk identification and operational discipline.