Senior Specialist, Manufacturing Technical Support

Novartis•Durham, CA

7d•$108,500 - $201,500•Onsite

About The Position

Imagine being the go-to expert who helps bring life-changing medicines to patients without interruption. As a Senior Specialist, Manufacturing Technical Support, you will play a critical role at the heart of our manufacturing operations, partnering closely with production teams to ensure every batch is delivered safely, efficiently, and in full compliance with quality standards. This is an opportunity to apply your technical expertise, drive continuous process improvements, solve complex manufacturing challenges, and influence the performance of innovative biopharmaceutical products in a highly regulated environment. Your work will directly contribute to operational excellence and our mission to reimagine medicine for patients around the world.

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.

Nice To Haves

Data Analytics

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.