Aseptic and Qualification Project Lead

Novartis•Millburn, NJ

2d•Onsite

About The Position

Are you passionate about developing innovative training solutions that enable operational excellence in a cutting-edge manufacturing environment? As the Aseptic and Qualification Project Lead, you will play a pivotal role at our RLT manufacturing site in Millburn, New Jersey, leading technical training and operator qualification programs that support aseptic operations. Partnering closely with manufacturing teams and subject matter experts, you will design and deliver impactful learning experiences, develop engaging training content, and help ensure associates are qualified and prepared to perform critical manufacturing activities safely and compliantly. This is a unique opportunity to influence workforce readiness, strengthen site training capabilities, and contribute to the delivery of life-changing radioligand therapies for patients around the world.

Requirements

Bachelor’s degree in Education, Science, or a related field, or equivalent experience, and 5 years’ relevant experience required with RLT aseptic pharmaceutical manufacturing.
Qualified in RLT manufacturing processes (Material Handling, Formulation, Dispensing, Cleaning, etc.).
Strong communication and analytical/problem solving skills.
Demonstrated history of working collaboratively across functions and sites.
Knowledge and understanding of cGMP requirements and the application of continuous improvement in a regulated environment.

Nice To Haves

Data Analytics

Responsibilities

Develop and implement technical training programs supporting aseptic manufacturing and radioligand therapy operations.
Lead operator qualification activities to ensure associates are prepared for manufacturing responsibilities.
Design engaging training materials, learning tools, and practical training experiences.
Deliver classroom and shop floor training for manufacturing associates and operational teams.
Partner with subject matter experts to identify training needs and strengthen learning effectiveness.
Monitor training outcomes, qualification progress, and compliance metrics to drive continuous improvement.
Maintain training documentation, qualification records, and learning resources in accordance with quality standards.