Director, CMC Supplier Management

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Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

💊 Pharmaceuticals

🔬 Science

💰 $10.5M Venture Round - Cristcot on 2025-06

Pharmaceuticals • Science

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

• Manage and oversee the relationship with suppliers including production schedules, equipment readiness, and line performance metrics while ensuring coordination and logistics for finished products • Identify and onboard new suppliers as needed, then build the relationships with the same while ensuring adherence to quality, timely delivery, and cost objectives • Develop supplier evaluation criteria, RFP content, technical due diligence materials, and vendor comparison summaries for prospective suppliers • Monitor supplier performance and conduct regular business and technical reviews including person-in-plant activities • Lead technology transfer of pharmaceutical and combination product processes from development to manufacturing including readiness, transfer package, risk management, and validation support • Support execution across the external supplier network including development campaigns, validation activities, manufacturing readiness, supply continuity, and resolution of manufacturing or technical issues • Ensure compliance with GMP, FDA, ISO, and company quality standards in all drug product and drug substance related operations • Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for overall assembly and packaging • Work closely with Engineering, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, and launches • Provide CMC technical input to Quality owned documentation and records including batch records, deviation reports, CAPAs, and change controls • Support audits and inspections by regulatory authorities and partners

🎯 Requirements

• Master’s degree in a Science related field, such as Pharmaceutics, Life Sciences, or related scientific field • Ph.D. degree in scientific discipline preferred • 10+ years of experience in pharmaceutical or combination product manufacturing • Strong knowledge of pharmaceutical regulations: FDA 21 CFR Part 820, FDA Guidance Documents, and pharmaceutical GMP standards • Proven ability to lead cross-functional teams and manage supplier relationships • Preferred experience in topical products, i.e. creams, lotions, suppositories, etc. • Experience with combination product design controls • Familiarity with electronic documentation systems (e.g., MES, eQMS, etc.) • Six Sigma, Lean, or PMP certification preferred • Ability to travel 20-25%.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development