Senior Manufacturing Tech Support for Biopharma

Novartis; Durham (NC); On-site; USD 108,500 - 201,500; Full time

Benefits offered by this job

Performance-based incentive

Health benefits

401(k) with company match

Equity eligibility

Job summary

Novartis in Durham, NC seeks a Senior Specialist, Manufacturing Technical Support to partner with production teams. The role ensures safe, compliant, and on-time batch execution, drives technical excellence, and maintains master manufacturing documents.

You will lead investigations, assess changes, and improve SOPs and electronic batch records. The position requires 7+ years in biopharma GMP, strong documentation skills, and knowledge of QbD, Six Sigma, and GMP standards.

Qualifications

• 7+ years of experience in biopharmaceutical GMP manufacturing operations.
• 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/biotechnology facility.
• Knowledge of Quality by Design (QbD) principles, Six Sigma and operational excellence tools.
• Excellent written and verbal communication skills; strong technical writing abilities.
• Ability to travel up to 20% to support activities at internal sites, vendor locations, and CMOs.

Responsibilities

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

Skills

GMP manufacturing

QbD principles

Six Sigma

CAPA implementation

Technical writing

travel up to 20%

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Novartis in Durham, NC seeks a Senior Specialist, Manufacturing Technical Support to partner with production teams. The role ensures safe, compliant, and on-time batch execution, drives technical excellence, and maintains master manufacturing documents.

You will lead investigations, assess changes, and improve SOPs and electronic batch records. The position requires 7+ years in biopharma GMP, strong documentation skills, and knowledge of QbD, Six Sigma, and GMP standards.