Director, GMP Operations & Readiness

Lonza

Walkersville (MD)

On-site

Confidential

Full time

14 days+

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Benefits offered by this job

Performance-related bonus

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Life insurance

Short-term disability

Long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza is seeking a Director of Operations to drive operational readiness for a U.S. growth investment in small molecule drug substance manufacturing.

You will lead activities from design through startup, ensuring GMP compliance and inspection readiness for reliable clinical and commercial manufacturing from day one. You will partner with Engineering, MSAT, Quality, Automation, and EHS to embed manufacturing requirements, define the future organization, staffing, and training, and manage risks

Qualifications

Bachelor’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences (advanced degree preferred).
12+ years of leadership experience in pharmaceutical or API manufacturing.
Experience with HPAPI, complex chemical synthesis, or chemical process manufacturing.

Responsibilities

We are seeking a Director, Operations to develop and execute the operational readiness strategy for a U.S. growth investment project.
Lead operational readiness activities including staffing plans, training strategy, and start-up preparation.
Define the future manufacturing organization, workforce structure, and governance.
Serve as primary Operations representative during facility and process design to ensure manufacturing needs are met.
Coordinate with Engineering, MSAT, Quality, Automation, and EHS to integrate requirements.
Ensure GMP compliance through commissioning, qualification, validation, and inspection readiness.
Lead technology transfer, process implementation, and product introduction.
Identify and mitigate risks related to staffing, equipment readiness, and start-up execution.
Build a high-performing operations organization and provide status updates to leadership.