Director, CMC & Technical Operations

Key Responsibilities

• Develop and execute the overall CMC strategy from Phase 1 through later-stage clinical development.
• Own the end-to-end manufacturing roadmap spanning source material, internal Phase 1 drug product, and external Phase 2 drug product.
• Serve as the cross-functional CMC lead, integrating Manufacturing, Process Development, Analytical Development, Quality, and Regulatory activities.
• Lead CMC planning for IND amendments, regulatory interactions, and clinical-stage manufacturing changes.

Internal Manufacturing & Process Robustness (Near-Term Priority)

• Provide technical and strategic oversight of internal Phase 1 drug product manufacturing and internal source-material manufacturing.
• Drive process robustness, characterization, and yield improvement of early clinical lots; lead resolution of manufacturing deviations and root-cause investigations.
• Ensure reliable, conforming clinical supply to support Phase 1 execution without interruption.
• Ensure consistent source-material supply and quality from the internal PCMV-free facility.
• Partner with the Operations Manager on daily execution, scheduling, and facility utilization (this role owns process and technical strategy, not routine production supervision).

External Manufacturing & Technology Transfer (Phase 2 Readiness)

• Lead evaluation, selection, qualification, and management of CDMO partners for Phase 2 drug product.
• Develop and execute the technology-transfer strategy for moving the internal process to external manufacturing — only after the internal process is sufficiently robust to transfer.
• Oversee process transfer, analytical transfer, engineering runs, and manufacturing readiness.
• Lead comparability strategy and change management for the internal-to-external transition, in partnership with Quality and Regulatory.
• Negotiate and manage the technical aspects of Quality Agreements, Master Service Agreements, and Statements of Work.

Supply Chain & Materials Management

• Develop supply strategies for critical raw materials and components across internal and external manufacturing.
• Assess supply risks and implement mitigation plans; support vendor qualification.
• Align manufacturing forecasts, inventory planning, and clinical supply requirements.

Regulatory & Inspection Support

• Serve as a primary CMC subject-matter expert for regulatory submissions and agency interactions.
• Support IND amendments, annual reports, and briefing packages.
• Participate in regulatory inspections, partner diligence, and quality audits.

Qualifications

• BS, MS, or PhD in engineering, biological sciences, biotechnology, or related discipline. PhD preferred.
• 8–12 years in biopharmaceutical, cell therapy, gene therapy, or related GMP manufacturing environments.
• Demonstrated experience leading CMC for clinical-stage products.
• Hands-on experience owning internal GMP process development, characterization, robustness, and investigations — not solely external/oversight roles.
• Experience leading technology transfer to a CDMO or between manufacturing sites.
• Strong understanding of GMP regulations, manufacturing controls, process development, and analytical development.
• Experience supporting CMC sections of INDs and regulatory submissions.

PREFERRED

• Direct experience with cell therapy in allogeneic/autologous products field.
• Experience taking an internally developed process from early clinical manufacturing to external scale-up.
• Experience with comparability strategy across manufacturing changes during clinical development.
• Experience in FDA or other regulatory agency interactions.

First 90 Days (Focus)

• Take ownership of the internal Phase 1 drug product process and source-material manufacturing.
• Assess current process performance; identify the drivers of yield variability and recent deviations, and define a robustness/characterization plan.
• Establish reliable, conforming clinical supply as the top operational objective.
• Map current cross-functional CMC workflows (Manufacturing, PD, AD, QA, QC, Regulatory) and identify integration gaps.

Success in the First 12 Months

• Stabilize the internal Phase 1 drug product process: improved robustness and yield, reduced deviations, and reliable conforming clinical supply.
• Ensure dependable source-material supply from the CRO.
• Define the Phase 2 external manufacturing strategy and complete an initial CDMO landscape assessment.
• Establish a technology-transfer and comparability framework for the internal-to-external transition (executed once the process is transfer-ready).
• Strengthen cross-functional CMC integration across Manufacturing, PD, AD, QA, QC, and Regulatory.

Pay Range

$190,000–$240,000 depending on experience