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
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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
- 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.