Senior Specialist, Manufacturing Technical Support

 Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities:

• Provide frontline technical support to manufacturing teams to ensure safe, compliant, and on-time batch execution.
• Serve as the 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.

Essential Requirements:

• Bachelor's degree in Engineering or Life Sciences with 7+ years of experience in biopharmaceutical GMP manufacturing operations.
• Demonstrated experience developing, revising, and maintaining manufacturing documentation in a regulated environment.
• Proven experience investigating complex manufacturing deviations and driving timely CAPA implementation.
• Strong knowledge of FDA regulations, GMP requirements, and quality management systems.
• Experience providing technical process support within a pharmaceutical or biotechnology manufacturing facility.
• Working knowledge of Quality by Design (QbD) principles, Six Sigma methodologies, and operational excellence tools.
• Excellent written and verbal communication skills with strong technical writing capabilities.
• Ability to travel up to 20% to support activities at internal sites, vendor locations, and CMOs.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $108,500 and $201,500 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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