Specialist, Clinical Manufacturing
Novartis
June 27, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Responsible for implementation of new clinical products into the facility, ensuring safe, compliant, and timely execution.
- Provide hands-on, front-line manufacturing support during clinical batch execution with shift teams.
- Author and manage master manufacturing documents (Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), Recipe, Quality Risk Assessment, Hazard Analysis).
- Support technology transfer projects, including new product change controls.
- Manage projects implementing significant improvements to clinical manufacturing processes.
- Partner cross-functionally with PMO, Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development.
- Support deviations, corrective actions, and internal or external audits for group-owned processes.
Essential Requirements:
- Bachelor’s degree in Engineering or Life Sciences and five years of experience in biopharmaceutical-based GMP manufacturing operations.
- Hands-on experience in technology transfer of biotechnology candidate clinical products and/or technology transfer of commercial products from site to site.
- Strong technical writing ability; excellent oral and written communication skills.
- In-depth knowledge of FDA regulations and Good Manufacturing Practice (GMP) systems.
- Applied knowledge of Quality by Design, six-sigma, and operational excellence tools.
- Ability to travel to other internal sites, vendors, and contract manufacturing organizations (typically <5%).
- Responsible for implementation of new clinical products into the facility, ensuring safe, compliant, and timely execution.
- Provide hands-on, front-line manufacturing support during clinical batch execution with shift teams.
- Author and manage master manufacturing documents (Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), Recipe, Quality Risk Assessment, Hazard Analysis).
- Support technology transfer projects, including new product change controls.
- Manage projects implementing significant improvements to clinical manufacturing processes.
- Partner cross-functionally with PMO, Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development.
- Support deviations, corrective actions, and internal or external audits for group-owned processes.
Essential Requirements:
- Bachelor’s degree in Engineering or Life Sciences and five years of experience in biopharmaceutical-based GMP manufacturing operations.
- Hands-on experience in technology transfer of biotechnology candidate clinical products and/or technology transfer of commercial products from site to site.
- Strong technical writing ability; excellent oral and written communication skills.
- In-depth knowledge of FDA regulations and Good Manufacturing Practice (GMP) systems.
- Applied knowledge of Quality by Design, six-sigma, and operational excellence tools.
- Ability to travel to other internal sites, vendors, and contract manufacturing organizations (typically <5%).