Director, Manufacturing & Ops Readiness — Remote

Lonza Group Ltd.

Walkersville (MD)

Hybrid

USD 199,000 - 232,000

Full time

14 days+
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401(k) matching
Life insurance
Short-term disability insurance
Long-term disability insurance
Employee assistance programs
PTO

Job summary

Lonza Group Ltd. seeks a Director of Manufacturing to lead operational readiness for US bioconjugate drug substance projects. You will drive GMP-compliant start-ups, site readiness, and manufacturing readiness across design, construction, and startup phases.

The role requires 12+ years in pharma/biotech ops, CDMO experience, and strong leadership with cross-functional teams. Expect a remote-now, future on-site East Coast or Midwest transition, with travel up to 25–30%.

Qualifications

  • Master’s degree in engineering, biotechnology, life sciences, pharma or related field preferred.
  • 12+ years of leadership experience in pharma/biotech/bioconjugate manufacturing.
  • Experience leading manufacturing ops in a CDMO with client programs.
  • Experience with bioconjugate drug substance manufacturing operations.
  • Proven track record on major capital projects and site starts.
  • Strong GMP knowledge and regulatory compliance experience.
  • Led large cross-functional teams and stakeholder management.
  • Experience building manufacturing orgs and talent development.
  • Customer-focused with CDMO program execution and delivery.
  • Strategic thinker with strong communication to executives.
  • Risk identification and mitigation across operations and projects.
  • Lean, Six Sigma, automation, and data integrity knowledge beneficial.
  • Willing to relocate to East Coast or Midwest; travel 25–30%.

Responsibilities

  • Develop and execute the operations readiness strategy for growth investment projects.
  • Serve as primary Operations rep through design, construction, commissioning, validation and startup.
  • Ensure GMP compliance, inspection readiness and throwable manufacturing from day one.
  • Collaborate with Engineering, Quality, MSAT, Automation, EHS, HR and Finance.
  • Lead readiness activities for start-up and transition to routine GMP manufacturing.
  • Define future manufacturing org design, staffing, shifts and interfaces.
  • Oversee reviews to integrate manufacturing requirements into design and equipment.
  • Provide governance updates, risk mitigations and leadership briefings.

Skills

Leadership
GMP manufacturing
Cross-functional leadership
Project management
Strategic thinking
Communication

Education

Master's degree in engineering or life sciences
Bachelor's degree with significant relevant experience

Tools

Lean Manufacturing
Six Sigma
Automation systems
Digital manufacturing platforms
Data integrity

Job description

Lonza Group Ltd. seeks a Director of Manufacturing to lead operational readiness for US bioconjugate drug substance projects. You will drive GMP-compliant start-ups, site readiness, and manufacturing readiness across design, construction, and startup phases.

The role requires 12+ years in pharma/biotech ops, CDMO experience, and strong leadership with cross-functional teams. Expect a remote-now, future on-site East Coast or Midwest transition, with travel up to 25–30%.

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