Senior Process Engineering Lead - Drug Substance & Product

BeOne Medicines

Hopewell (NJ)

On-site

USD 139,000 - 184,000

Full time

6 days ago

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Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Paid Time Off

Wellness

Job summary

BeOne Medicines seeks a Senior Manager of Process Engineering for Dug Substance and Drug Product at the Hopewell, NJ site. Lead a hands-on team to support tech transfers, equipment selection, and day-to-day manufacturing.

You will drive deviation investigations, regulatory inspections support, and continuous improvement, working with Operations, Quality, and Automation to ensure right-first-time quality. Requires 7+ years GMP pharma operations experience and a BS in engineering; travel up to 5%

Qualifications

Minimum 7 years of GMP pharma operations support.
Experience leading technical teams and managing complex priorities.
Proven ability in technology transfer and equipment qualification.
Strong analytical problem-solving and proactive decision-making.
Proficient in MS Office and project management tools.

Responsibilities

Lead technical teams with a focus on right-first time quality.
Oversee design, selection, and troubleshooting of systems and equipment for Drug Substance and Drug Product manufacturing.
Support technology transfer and qualification studies for processes, systems, and facilities.
Partner with Operations, Quality, and Automation to ensure compliance and execution.
Develop and review technical documentation and lead fault analysis remediation.
Support operations with troubleshooting and issue resolution; travel up to 5%.