CMC & Technical Operations Leader (Phase 1–2 Readiness)

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

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.