Specialist, Clinical Manufacturing

Novartis•Durham, NC

2d•Onsite

About The Position

This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. NOTE: This role is typically Monday–Friday working standard business hours. However, during active clinical campaigns, working overtime, nights, and weekends will be required. If you’re energized by seeing new clinical therapies move from idea to execution, this is your opportunity to make a visible impact. As a Specialist, Clinical Manufacturing, you will play a hands-on role at the heart of manufacturing execution, introducing new clinical products into a Good Manufacturing Practice environment. Working closely with Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development, you’ll translate technical knowledge into compliant, real-world manufacturing outcomes. This role offers a unique blend of shop-floor presence, technical authorship, and project ownership—giving you direct visibility into how your expertise enables safe, timely delivery of medicines that matter.

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 required.
Excellent oral and written communication skills.
In-depth knowledge of Food and Drug Administration regulations and Good Manufacturing Practice systems.
Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
Ability to travel to other internal sites, vendors, and contract manufacturing organizations, as required, typically less than five percent.

Nice To Haves

Data Analytics
digital skills
General Hse Knowledge
gmp knowledge
process excellence
Resilience

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 of assigned products, including Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), and Recipe, Quality Risk Assessment, and Hazard Analysis.
Support technology transfer projects, including new product change controls.
Manage projects implementing significant improvements to clinical manufacturing processes.
Partner cross-functionally with the PMO group, Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development teams.
Support deviations, corrective actions, and internal or external audits for group owned processes.