About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:

The Director of CMC Supplier Management will support Cristcot in its growth by managing all suppliers supporting drug substance and drug product manufacturing of drug-device combination products. This role is responsible for identifying and managing drug substance, drug product, and combination product suppliers to ensure reliable, compliant, and cost-effective production of pharmaceutical components and finished combination products.

Primary Relationships:

• Within Cristcot: The Director, CMC Supplier Management will work closely with the Senior Director of CMC Manufacturing, Quality, and Regulatory Affairs.
• Outside Cristcot: The Director, CMC Supplier Management will partner with contract manufacturers (CMOs) and suppliers.

Primary Job Responsibilities:

The Director, CMC Supplier Management, will manage and oversee the relationship with suppliers including production schedules, equipment readiness, and line performance metrics while ensuring coordination and logistics for finished products. They will also identify new suppliers as needed. The Director, CMC Supplier Management, will support the day-to-day operations for pharmaceutical product manufacturing across clinical and commercial stages.

The Activities of the Director, CMC Supplier Management:

• 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.

Skills and Qualifications:

• 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%.