Specialist, Manufacturing Technical Support

Novartis•Durham, CA

4d•Onsite

About The Position

Make a meaningful impact at the heart of biopharmaceutical manufacturing—where your expertise ensures life-changing therapies are produced safely, efficiently, and to the highest quality standards. As a Specialist in Manufacturing Technical Support, you’ll play a critical role partnering with production teams to optimize processes, solve complex challenges, and continuously improve performance. Your contributions will directly influence product quality, compliance, and innovation, helping deliver essential medicines to patients who need them most.

Requirements

Bachelor of Science degree in engineering or life sciences with relevant GMP manufacturing experience
Minimum 5 years in biopharmaceutical GMP operations or 3 years in gene therapy manufacturing
Experience authoring manufacturing documents and investigating complex deviations
Strong knowledge of FDA regulations, cGMP systems, and pharmaceutical or biotech environments
Experience supporting process troubleshooting, deviations, OOS, and OOE investigations
Applied experience with Quality by Design (QbD), Six Sigma, and operational excellence tools
Demonstrated experience with change control, CAPA management, and risk assessments
Excellent written and verbal communication skills with strong technical writing capability

Nice To Haves

Experience with upstream processing, cell expansion, or media preparation
Exposure to gene therapy manufacturing
Data Analytics
digital skills
General Hse Knowledge
gmp knowledge
process excellence
Resilience

Responsibilities

Provide real-time technical support to manufacturing teams to ensure safe, compliant, and on-time batch execution
Collaborate with shift teams to resolve process issues and maintain uninterrupted production
Revise and maintain master manufacturing documentation, including batch records, bills of material, and recipes
Ensure critical process parameters remain within defined instructions and validated ranges
Support technical assessments, root cause analysis, and quality risk assessments for process improvements
Manage process changes through established change control procedures to ensure compliance
Develop and update standard operating procedures and electronic manufacturing records
Act as subject matter expert, providing insights on product and process trends and driving innovation
Lead and author investigations, ensuring timely closure and effective CAPAs
Support process monitoring, verification, and continuous improvement initiatives to enhance productivity and quality