Director, CMC & Technical Operations

Planet Pharma; Germantown (MD); On-site; USD 180,000 - 260,000; Full time

Job summary

Planet Pharma seeks a technical CMC leader to own the strategy across Phase 1 and readiness for Phase 2. You will provide hands-on technical oversight of internal Phase 1 production and internal source-material manufacturing while building an external manufacturing strategy for Phase 2.

You'll collaborate closely with Quality, Analytical Development, Process Development, Regulatory Affairs, Operations, and external partners.

Qualifications

• BS/MS/PhD in engineering, biological sciences, biotechnology, or related discipline.
• 8–12 years in biopharmaceutical GMP manufacturing environments.
• Demonstrated CMC leadership for clinical-stage products.
• Hands-on GMP process development, characterization, and investigations.

Responsibilities

• Develop and execute the overall CMC strategy from Phase 1 through later-stage development.
• Own end-to-end manufacturing roadmap from source material to internal Phase 1 and external Phase 2 drug product.
• Lead cross-functional CMC planning with Manufacturing, Process Development, Analytical Development, QA and Regulatory.
• Lead CMC planning for IND amendments, regulatory interactions, and clinical-stage manufacturing changes.
• Oversee internal manufacturing robustness, deviations, and root-cause investigations.
• Drive technology transfer to CDMOs and manage external manufacturing readiness.

Skills

CMC leadership

Cross-functional

Technology transfer

Regulatory liaison

Process development

Quality collaboration

Education

BS/MS/PhD in engineering or biosciences

Job description

• 
  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