Director, CMC & Technical Operations

• Note:
  
  this role owns process and technical strategy plus Phase 1 production oversight and Phase 2 readiness. Routine daily manufacturing supervision remains with the Operations Manager. The profile sought is a technical CMC leader who will work in the process — not a hands-off strategist, given the near-term internal stabilization need
• .The role carries a dual mandate: provide hands-on technical oversight of internal Phase 1 production and source-material manufacturing — including driving process robustness and yield of early clinical lots — and build the external manufacturing strategy and technology-transfer path required for Phase 2
• .This individual partners closely with Quality, Analytical Development, Process Development, Regulatory Affairs, Operations, and external partners. This is a highly visible leadership role reporting to the CTOO
• .This role owns the technical strategy across and the planning and execution of the internal-to-external transition for drug product

.
Key Responsibiliti

• hip Develop and execute the overall CMC strategy from Phase 1 through later-stage clinical developme
• nt.
  
  Own the end-to-end manufacturing roadmap spanning source material, internal Phase 1 drug product, and external Phase 2 drug produ
• ct.
  
  Serve as the cross-functional CMC lead, integrating Manufacturing, Process Development, Analytical Development, Quality, and Regulatory activiti
• es.
  
  Lead CMC planning for IND amendments, regulatory interactions, and clinical-stage manufacturing chang
• es.
  
  Internal Manufacturing & Process Robustness (Near-Term Priori
• ty)
  Provide technical and strategic oversight of internal Phase 1 drug product manufacturing and internal source-material manufacturi
• ng.
  
  Drive process robustness, characterization, and yield improvement of early clinical lots; lead resolution of manufacturing deviations and root-cause investigatio
• ns.
  
  Ensure reliable, conforming clinical supply to support Phase 1 execution without interrupti
• on.
  
  Ensure consistent source-material supply and quality from the internal PCMV-free facili
• ty.
  
  Partner with the Operations Manager on daily execution, scheduling, and facility utilization (this role owns process and technical strategy, not routine production supervisio
• n).External Manufacturing & Technology Transfer (Phase 2 Readine
• ss)
  Lead evaluation, selection, qualification, and management of CDMO partners for Phase 2 drug produ
• ct.
  
  Develop and execute the technology-transfer strategy for moving the internal process to external manufacturing — only after the internal process is sufficiently robust to transf
• er.
  
  Oversee process transfer, analytical transfer, engineering runs, and manufacturing readine
• ss.
  
  Lead comparability strategy and change management for the internal-to-external transition, in partnership with Quality and Regulato
• ry.
  
  Negotiate and manage the technical aspects of Quality Agreements, Master Service Agreements, and Statements of Wo
• rk.
  
  Supply Chain & Materials Managem
• ent Develop supply strategies for critical raw materials and components across internal and external manufacturi
• ng.
  
  Assess supply risks and implement mitigation plans; support vendor qualificati
• on.
  
  Align manufacturing forecasts, inventory planning, and clinical supply require men
• ts.
  
  Regulatory & Inspection Supp
• ort Serve as a primary CMC subject-matter expert for regulatory submissions and agency interactio
• ns.
  
  Support IND amendments, annual reports, and briefing packag
• es.
  
  Participate in regulatory inspections, partner diligence, and quality audi

ts.
Requ

• ired
  BS, MS, or PhD in engineering, biological sciences, biotechnology, or related discipline. PhD prefe
• rred.
  8–12 years in biopharmaceutical, cell therapy, gene therapy, or related GMP manufacturing environm
• ents.
  
  Demonstrated experience leading CMC for clinical-stage prod
• ucts.
  
  Hands-on experience owning internal GMP process development, characterization, robustness, and investigations — not solely external/oversight r
• oles.
  
  Experience leading technology transfer to a CDMO or between manufacturing s
• ites.
  
  Strong understanding of GMP regulations, manufacturing controls, process development, and analytical develop
• ment.
  
  Experience supporting CMC sections of INDs and regulatory submiss

ions.
P…