Senior Director, CMC Manufacturing

Job Summary:

The Senior Director of CMC will support Cristcot in its growth by leading the manufacturing operations of drug-device combination products. This role is responsible for managing internal timelines and contract manufacturers (CMOs) to ensure reliable, compliant, and cost-effective production of pharmaceutical components and finished combination products.

Primary Relationships:

• Within Cristcot, the Senior Director, CMC will bring deep experience in pharmaceutical manufacturing, along with a strong understanding of pharmaceutical GMPs, FDA 21 CFR Part 820, and ISO 13485.
• Outside Cristcot, the Senior Director, CMC will partner with contract manufacturers (CMOs) and additional vendors.

Primary Job Responsibilities:

The Senior Director, CMC will manage and oversee production schedules, equipment readiness, resource allocation, and line performance metrics ensuring coordination and logistics for finished products. The Senior Director, CMC will lead the day-to-day operations for pharmaceutical product manufacturing across clinical and commercial stages.

The Activities of the Senior Director, CMC Manufacturing:

• Ensure compliance with GMP, FDA, ISO, and company quality standards in all pharmaceutical and drug substance related operations.
• Work closely with Engineering, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, and launches.
• Support technology transfer of pharmaceutical and combination product processes from development to manufacturing.
• Lead relationships with external manufacturing partners, ensuring adherence to quality, delivery, and cost objectives.
• Monitor supplier performance and conduct regular business and technical reviews including man-in-plant activities.
• Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for overall assembly and packaging.
• Lead validation efforts (equipment, process, packaging, and cleaning), ensuring compliance with regulatory standards.
• Ensure accurate and complete documentation 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 disciple 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.
• Preferred experience in topical products, i.e. creams, lotions, suppositories, etc.
• Proven ability to lead cross-functional teams and manage contract manufacturing relationships
• Experience with combination product design controls
• Familiarity with electronic documentation systems (e.g., MES, eQMS, etc.).
• Six Sigma, Lean, or PMP certification.
• Candidates located in the San Antonio and/or Austin area will be given priority consideration.