Specialist, Clinical Manufacturing

Novartis • Durham, CA

1d • Onsite

About The Position

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 will 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. This role is based in Durham, NC, and typically involves standard business hours, Monday-Friday, but requires overtime, nights, and weekends during active clinical campaigns.

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.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees