Senior Biopharma Manufacturing Technical Support

Novartis Group Companies

Durham (NC)

On-site

USD 108,500 - 201,500

Full time

14 days+

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Job summary

Novartis Group of Companies seeks a Senior Specialist, Manufacturing Technical Support, to partner with production teams in Durham, NC, delivering safe, compliant batch execution onsite. You will act as SME for products and processes, drive technical excellence, and maintain critical manufacturing documents to support quality and efficiency.

The role requires 7+ years in biopharmaceutical GMP manufacturing, strong documentation experience, and the ability to travel up to 20% as needed.

Qualifications

Bachelor's degree in Engineering or Life Sciences with 7+ years of biopharmaceutical GMP manufacturing experience.
Experience developing, revising, and maintaining manufacturing documentation in a regulated environment.
Proven experience investigating deviations and driving CAPA implementation.

Responsibilities

Provide frontline technical support to manufacturing teams for safe, compliant, and on-time batch execution.
Serve as SME for assigned products and processes, driving technical excellence and process knowledge.
Review and maintain master manufacturing documents, including MBRs, BOMs, and manufacturing recipes.
Monitor critical process parameters and ensure compliance with approved manufacturing instructions and quality requirements.
Lead and support manufacturing investigations, root cause analyses, and timely CAPA implementation.
Assess technical changes and ensure execution through established change control procedures.
Develop, review, and continuously improve manufacturing SOPs and electronic batch records.
Support ongoing process verification through data analysis, product performance monitoring, and CAPA effectiveness tracking.
Perform technical assessments and resolution of process-related issues, including deviations, complaints, OOS, and OOE events.
Lead or support process validations, technology transfers, new technology implementation, and continuous improvement initiatives while maintaining GMP inspection readiness.