Specialist, Clinical Manufacturing

Novartis • Durham, CA

1d • Onsite

About The Position

As a Specialist, Clinical Manufacturing, you will be instrumental in translating new clinical therapies from concept to execution within a Good Manufacturing Practice (GMP) environment. This hands-on role involves introducing new clinical products and providing front-line manufacturing support during clinical batch execution. You will collaborate closely with various cross-functional teams including Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development to ensure compliant and timely manufacturing outcomes. The position offers a unique blend of shop-floor presence, technical documentation authorship, and project management, directly contributing to the safe and timely delivery of essential medicines.

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 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

• Implement 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 for assigned products, including Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), Recipe, Quality Risk Assessment, and Hazard Analysis.
• Support technology transfer projects, including new product change controls.
• Manage projects focused on 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

• Comprehensive benefits package that includes 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