Senior GMP Cell Therapy Manufacturing & Facilities Lead

Planet Pharma; Germantown (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

Planet Pharma is seeking a Senior Manufacturing & Facilities Specialist to lead GMP cell therapy manufacturing and maintain live operations of facilities, utilities and equipment. You will work in the cleanroom with the manufacturing team, owning day-to-day execution, tracking KPIs, and coordinating with QA, Validation and MSAT to ensure patient batches are made safely, on time and in compliance.

As an early member of a start-up, you will wear multiple hats across manufacturing, facilities and

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences or related field.
• 7–10 years GMP manufacturing experience, ideally in cell therapy.
• 3+ years supporting facilities/equipment in a GMP cleanroom.
• Hands-on aseptic execution in Grade A/B cleanrooms.
• Working knowledge of FDA and EU GMP regulations.
• Track record of supporting regulatory inspections.
• Lean, Six Sigma or similar continuous improvement credentials a plus.

Responsibilities

• Execute GMP cell therapy manufacturing in Grade A/B cleanrooms per batch records and SOPs.
• Perform aseptic manipulations in biosafety cabinets and operate closed/semi-closed systems.
• Complete batch records, logbooks and equipment records contemporaneously.
• Maintain chain of identity and chain of custody for patient material.
• Execute aseptic process simulations and maintain gowning qualification.
• Perform in-process sampling and support line clearance, room release and changeover.
• Own Manufacturing department: production schedule, batch readiness and right-first-time performance.
• Represent Manufacturing in cross-functional team meetings, reporting status and resource needs.
• Run routine operations to support clinical manufacturing schedules.
• Plan facility shutdowns, maintenance windows and changeovers with QA.
• Track and report KPIs: equipment uptime, PM/calibration, environmental excursions, deviation and CAPA closure.
• Manage service contracts and spares inventory; input to budgets.

Skills

Leadership

Self-motivation

Prioritisation

Continuous improvement

Start-up mindset

Compliance mindset

Technical depth

Ownership

Collaboration

Clear communication

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Tools

Rotea

CT-5

CliniMACS Prodigy

Sepax

Lovo

Xuri/WAVE

G‑Rex

CRFs

LN2 storage

Biosafety cabinets

Job description

Planet Pharma is seeking a Senior Manufacturing & Facilities Specialist to lead GMP cell therapy manufacturing and maintain live operations of facilities, utilities and equipment. You will work in the cleanroom with the manufacturing team, owning day-to-day execution, tracking KPIs, and coordinating with QA, Validation and MSAT to ensure patient batches are made safely, on time and in compliance.

As an early member of a start-up, you will wear multiple hats across manufacturing, facilities and