Director / Senior Director, CMC Supply Chain and Quality Control

Company: ALLInBio, Inc.
Location: Stanford
Posted on: March 13, 2026

Job Description:

Location Headquarter: Palo Alto, CA, USA Virtual-but-local model: candidates may work remotely but must be available for weekly in-person meetings at our Palo Alto headquarter. Company Overview We are an early-stage biotechnology company focused on developing innovative therapies for patients with serious unmet medical needs, with an emphasis on autoimmune, inflammatory and fibrotic diseases. We operate in a fast-paced, highly collaborative, and science-driven environment, and value entrepreneurial individuals who enjoy building processes, solving complex problems, and contributing hands-on to the advancement of clinical programs. Role Summary The Director / Senior Director, CMC Supply Chain and Quality Control will oversee CMC supply chain activities and quality control activities, and coordinate clinical supply to support clinical development and regulatory submissions. This role ensures the timely availability of high-quality materials for development and global clinical programs, working with external CMC CROs and cross-functionally with Regulatory, Quality, and Clinical Operations. This position is ideal for a leader experienced in virtual or lean biotech environments with multiple external partners supporting testing, packaging, and logistics. Key Responsibilities CMC Supply Chain Management Oversee CMC supply chain activities for drug substance and drug product. Manage clinical supply forecasting, inventory, and material availability. Coordinate packaging, labeling, and global distribution of clinical materials. Ensure cold chain integrity, import/export compliance, and proper storage conditions. Track material readiness, inventory levels, and supply risks to support clinical programs. Quality Control & Analytical Oversight Oversee analytical testing coordination Ensure release testing, stability programs, and analytical schedules are executed. Review certificates of analysis, test reports, and analytical documentation. Collaborate with QA on deviations, investigations, and compliance requirements. Ensure quality control processes meet regulatory and GMP standards. Vendor & Partner Coordination Coordinate with external laboratories, packaging vendors, and logistics providers. Track vendor deliverables and timelines to ensure timely execution of testing, packaging, and distribution activities. Maintain operational communication with partners to address supply chain and quality issues. Regulatory & Documentation Support Support preparation and review of global CMC documentation for regulatory submissions (IND/CTA). Maintain records related to supply chain, testing, and quality control activities. Ensure documentation meets regulatory expectations and inspection readiness. Qualifications Education: PhD, MS, or BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline. Experience: Director: ~10–12 years in CMC supply chain, quality control, or operational roles. Senior Director: ~15 years with leadership experience in CMC supply chain and QC. Required Expertise: Experience overseeing CMC supply chain activities and quality control operations. Strong understanding of GMP analytical testing and quality control processes. Experience managing clinical supply logistics and material tracking. Familiarity with CMC documentation supporting regulatory submissions. Experience in small molecule CMC work Preferred Experience: Experience in small to mid-size biotechnology companies. Experience working with outsourced laboratories, CDMOs, and logistics providers. Knowledge of clinical supply management and regulatory expectations. Leadership & Competencies Strong organizational and operational management skills Ability to manage complex timelines and multiple vendors Excellent cross-functional communication Strong attention to documentation, compliance, and detail Ability to identify operational risks and implement solutions Why Join Us Opportunity to make a direct and visible impact on development programs High level of responsibility and contribution in a growing startup Collaborative, rigorous, and science-first culture Competitive compensation and benefits

Keywords: ALLInBio, Inc., San Francisco , Director / Senior Director, CMC Supply Chain and Quality Control, Science, Research & Development , Stanford, California