Associate Director, Raw Materials MSAT

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.

Key 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

Investigations, CAPA & Quality Systems

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.

Cross-Functional Leadership

Partner closely with:

Manufacturing Operations

Quality Assurance

QC Microbiology

MSAT

Facilities & Engineering

Supply Chain

Regulatory Affairs

Support strategic planning for commercial manufacturing readiness and network expansion.

Team Leadership

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.

Qualifications

Education

Bachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.

Advanced degree preferred.

Experience

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

Leadership Competencies

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

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.