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
- hipDevelop 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
- entDevelop 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 requiremen
- ts.Regulatory & Inspection Supp
- ortServe 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.
Pre
- ferred
Direct experience with cell therapy in allogeneic/autologous products - field.Experience taking an internally developed process from early clinical manufacturing to external sc
- ale-up.Experience with comparability strategy across manufacturing changes during clinical devel
- opment.Experience in FDA or other regulatory agency intera
ctions.
First 90 Days
- (Focus)
These priorities are immediate and do not depend on clinical mi - lestones:Take ownership of the internal Phase 1 drug product process and source-material manuf
- acturing.Assess current process performance; identify the drivers of yield variability and recent deviations, and define a robustness/characterizat
- ion plan.Establish reliable, conforming clinical supply as the top operational o
- bjective.Map current cross-functional CMC workflows (Manufacturing, PD, AD, QA, QC, Regulatory) and identify integrat
ion gaps.
Success in the First
- 12 Months
Stabilize the internal Phase 1 drug product process: improved robustness and yield, reduced deviations, and reliable conforming clini - cal supply.Ensure dependable source-material supply fr
- om 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 trans
- fer-ready).Strengthen cross-functional CMC integration across Manufacturing, PD, AD, QA, QC, and