Cristcot Management Company INC

Cristcot Management Company INC

Director, CMC Supplier Management

Remote (United States) · Director

Sponsorship not specified$20k-$25kDetected 23 days ago
Supply ChainLogisticsProcess ImprovementGMPFDA RegulatoryLean ManufacturingRegulatory Affairs

About the role

  • 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.
  • They will also identify new suppliers as needed.

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.
  • 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.
  • 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.
  • Support audits and inspections by regulatory authorities and partners.
  • The Director, CMC Supplier Management will partner with contract manufacturers (CMOs) and suppliers.

Requirements

  • Master's degree in a Science related field, such as Pharmaceutics, Life Sciences, or related scientific field.
  • 10+ years of experience in pharmaceutical or combination product manufacturing.
  • Skills and Qualifications: Master's degree in a Science related field, such as Pharmaceutics, Life Sciences, or related scientific field.

Nice to have

  • 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%.
  • Ph.D. degree in scientific discipline preferred.

Compensation

  • $20k-$25k

Company info

  • 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.
Apply directly at Cristcot Management Company INC →Create a free account for alerts like thisView Cristcot Management Company INC immigration profile

This listing is sourced directly from Cristcot Management Company INC's careers page and normalized into a canonical job model.