Head of Gene Therapy Manufacturing Operations

Precigen

Germantown, Northern (MD, KY)

Hybrid

USD 170,000 - 210,000

Full time

4 days ago

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Job summary

Precigen is seeking a Director of Gene Therapy Manufacturing, Drug Substance in Germantown, MD. This full‑time role leads manufacturing operations for clinical and commercial drug substances, guiding site readiness, organizational design, governance, and performance standards.

You will oversee production planning, tech transfer, and continuous improvement efforts across upstream and downstream processes. The position requires deep cGMP expertise, hands-on leadership, and a track record of

Qualifications

Bachelor’s degree in Biology, Chemistry, Chemical Engineering or a related discipline.
10+ years of relevant cGMP experience in biologics or regulated manufacturing.
5+ years of people leadership in Manufacturing/Engineering/Operations.
Strong knowledge of cGMP, quality systems and regulatory readiness.

Responsibilities

Provide leadership for current and future manufacturing teams (upstream/downstream).
Lead production planning, scheduling, and site ramp-up activities.
Ensure safety, quality, and compliance across manufacturing operations.
Drive continuous improvement and Lean initiatives.
Develop and mentor manufacturing managers and supervisors.