Novartis

Novartis

Senior Specialist, Manufacturing Technical Support

Durham · Senior

No sponsorshipDetected 79 days ago
Data AnalysisProcess ImprovementCustomer SupportGMPFDA RegulatoryResearchCommunicationWriting

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Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

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Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • This position will be located in Durham, NC and will be an onsite role.
  • Imagine being the go-to expert who helps bring life-changing medicines to patients without interruption.
  • Your work will directly contribute to operational excellence and our mission to reimagine medicine for patients around the world.

Responsibilities

  • Provide frontline technical support to manufacturing teams to ensure safe, compliant, and on-time batch execution.
  • Review and maintain master manufacturing documents, including MBRs, BOMs, and manufacturing recipes.
  • Lead and support manufacturing investigations, root cause analyses, and timely CAPA implementation.
  • 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.
  • Demonstrated experience developing, revising, and maintaining manufacturing documentation in a regulated environment.
  • We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Requirements

  • Bachelor's degree in Engineering or Life Sciences with 7+ years of experience in biopharmaceutical GMP manufacturing operations.
  • Proven experience investigating complex manufacturing deviations and driving timely CAPA implementation.
  • Strong knowledge of FDA regulations, GMP requirements, and quality management systems.

Compensation

  • 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.
  • $108,500.00 - $201,500.00

Benefits

  • 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.

Equal opportunity

  • The Novartis Group of Companies are Equal Opportunity Employers.
  • The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
  • EEO Statement:
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This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.