Specialist, Manufacturing Technical Support

Novartis • Durham, NC

6h • 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

Benefits

• health, life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior