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 managementLead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturabilityPartner 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 partnersEstablish 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 robustnessAct as the subject matter expert on raw material science within CMC technical teamsConduct risk assessments, supplier evaluations, and manage post-approval changes related to raw materialsCollaborate 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 initiativesReview deviations, change controls, and risk assessments impacting raw material operations, including vendor notificationsDrive continuous improvement initiatives to strengthen robustness of raw material program. Cross-Functional Leadership Partner closely with:Manufacturing OperationsQuality AssuranceQC MicrobiologyMSATFacilities & EngineeringSupply ChainRegulatory AffairsSupport strategic planning for commercial manufacturing readiness and network expansion. Team Leadership Build and lead high-performing raw material team focused on risk mitigation strategiesDevelop training programs focused on:Material QualificationIn-coming receipt, inspection and testingcGMP cleanroom practicesFoster 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 managementProven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturingStrong organizational, problem-solving, and communication skills with the ability to influence decisions across teamsExperience with commercial product lifecycle management including post-approval changes and supplier updatesComprehensive understanding of cGMP requirements and regulatory expectations related to raw materials Leadership Competencies Strong executive communication and inspection interaction skillsAbility to influence across Quality, Manufacturing, and Technical OperationsStrategic systems-thinking capabilityStrong operational judgment under high-pressure manufacturing conditionsAbility to build a proactive culture around continuous improvementMay lead a team of engineers/scientistsExcellent mentoring and organizational leadership skillsExhibit 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.