Senior GMP Cell Therapy Manufacturing & Facilities Lead

Clinical Dynamix, Inc.; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Clinical Dynamix, Inc. in Germantown, MD seeks a Senior Manufacturing & Facilities Specialist to execute GMP cell therapy manufacturing and manage facilities, equipment, and GMP compliance.

The role works hands-on in cleanrooms, coordinating with QA, Validation, MSAT and cross‑functional teams while maintaining safety and patient batch quality. You will own day‑to‑day manufacturing execution, lead facilities operations, and drive process improvements across Operations, reporting status and risks

Qualifications

• Bachelor's degree in Engineering, Life Sciences or a related field, or equivalent experience.
• 7–10 years of GMP manufacturing experience, ideally all in cell therapy, with at least 5 years hands‑on.
• 3+ years supporting facilities and/or equipment in a GMP cleanroom environment.
• Hands‑on aseptic execution and familiarity with equipment qualification and calibration.

Responsibilities

• Execute GMP cell therapy manufacturing processes in Grade A/B cleanrooms per batch records and SOPs.
• Own day-to-day manufacturing execution, batch readiness and right‑first‑time performance.
• Represent Manufacturing in cross‑functional meetings and audits; report status and resource needs.
• Plan facility shutdowns, maintenance windows and changeovers with QA to minimize impact on batches.
• Track operational KPIs and manage service contracts, spares, and input to budgets.
• Lead process improvement and training across Operations; drive SOP updates and CAPA closures.

Skills

GMP manufacturing

cell therapy

facility operations

equipment maintenance

leadership

Education

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

Tools

Rotea/CT-5 platforms

CliniMACS Prodigy

Sepax

Lovo

CMMS (Maximo)

Job description

Clinical Dynamix, Inc. in Germantown, MD seeks a Senior Manufacturing & Facilities Specialist to execute GMP cell therapy manufacturing and manage facilities, equipment, and GMP compliance.

The role works hands-on in cleanrooms, coordinating with QA, Validation, MSAT and cross‑functional teams while maintaining safety and patient batch quality. You will own day‑to‑day manufacturing execution, lead facilities operations, and drive process improvements across Operations, reporting status and risks