Associate Expert Drug Supply (Operator)

Job Description

350+ trials, about 25,000+ patients per year! This is your chance to reimagine medicine in 2021.

As part of the Technical Research and Development team, this role is critical in making sure that sterile clinical supplies are manufactured to the highest quality aseptic standards, ensuring our patient safety in clinical trials.

• Demonstrate a good solid understanding of the GMP requirements associated with the cleaning, changeover, setup, startup, operation, breakdown and sampling of compounding areas and filling lines for sterile clinical products. Good aseptic technique and understanding of sterile garbing requirements, good documentation practices according the cGMP requirements for all records.
• Perform visual and physical inspections of in process and finished products as requested. Assist in packaging and shipment of bulk finished goods to GCS
• Operate under the direct supervision/leadership of a Lead Operator and/or Supervisor
• Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own field. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
• Work according to appropriate SOP's, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines. Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regulations.
• Interact/collaborate with other functions in Development to facilitate transfer of knowledge and results with the production of clinical supplies. Monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.