Senior Early-Phase PD GMP Operations Lead

Lonza Biologics, Inc.

Tampa (FL)

On-site

Confidential

Full time

14 days+
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Benefits offered by this job

Relocation assistance
Career development programs
Competitive benefits

Job summary

Lonza Biologics, Inc. in Tampa, FL is seeking a Product Development Manager for GMP Operations to lead early‑phase drug product manufacturing and packaging, overseeing PD GMP spaces, equipment selection, and engineering build‑outs.

You will guide cross‑functional teams, ensure cGMP compliance, readiness for inspections, and collaborate with quality, manufacturing, and project groups to deliver timely, cost‑effective work. A Ph.D. or M.S. in science with 10+ years in GMP environments is required.

Qualifications

  • 10+ years of experience in early‑phase GMP drug product manufacturing.
  • Strong understanding of cGMP regulations and audit readiness.
  • Scientific degree required with emphasis on applying knowledge to drug product development.

Responsibilities

  • Lead and develop PD GMP manufacturing operations for early‑phase drug products.
  • Design, oversee, and maintain PD GMP spaces, including equipment selection and engineering build‑outs.
  • Serve as SME for PD GMP activities, supporting projects and new technologies.

Skills

Leadership
GMP knowledge
Regulatory knowledge
Stakeholder management
Communication

Education

MS or PhD in science

Tools

Engineering drawings
Quality systems

Job description

Lonza Biologics, Inc. in Tampa, FL is seeking a Product Development Manager for GMP Operations to lead early‑phase drug product manufacturing and packaging, overseeing PD GMP spaces, equipment selection, and engineering build‑outs.

You will guide cross‑functional teams, ensure cGMP compliance, readiness for inspections, and collaborate with quality, manufacturing, and project groups to deliver timely, cost‑effective work. A Ph.D. or M.S. in science with 10+ years in GMP environments is required.

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