QC Chemist

Band

Level 3

 

Job Description Summary

About this role:

We are seeking a highly skilled and experienced QC Chemist to join our Quality Control team. The ideal candidate will have a strong background in analytical chemistry, wet chemistry techniques and knowledge in ICP analysis. The candidate will have a strong technical writing skill and experience with validation of analytical methods and qualification of analytical equipment. This position is crucial to ensure the quality, safety, and compliance of our products, contributing to the regulatory adherence and scientific integrity of our testing procedures. The QC Chemist is responsible for the quality control testing of the radioisotopes, incoming raw materials, and packaging components.

Location: Indianapolis, IN #LI-Onsite

Shift: This position involves shift work which will be defined through site start up and commercialization readiness.

 

Job Description

Key Responsibilities: 

Demonstrates technical experience in aspects related to quality control testing, including QC method and instrument qualifications as well as technical transfers from third party laboratories or other Novartis sites. Supports and provides technical insight for QC testing, while ensuring documentation completion remains in full compliance with GMP regulations, Novartis procedures, and product specifications. 

• Executes testing for radioisotopes and incoming materials. 

• Execute testing associated to qualification and validation protocols. 

• Supports deviation investigations and OOS/OOT/OOE investigations with testing, if needed.

• Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role. 

• Prepares applicable documents, forms, and records, such as method or instrument qualification/validation records, and follows Good Documentation Practices. 

• Supports internal and external Audits and Inspections, if needed. 

Essential Requirements: 

• Education: Bachelor’s degree in chemistry. Master's Degree is a plus. 

• A minimum of 2 years of experience in a cGMP or aseptic environment with prior Quality Control and analytical chemistry experience, expertise in method validation and instrument qualification is a plus. 

• In-depth knowledge of QC chemistry lab instrumentation (principles, operation, and troubleshooting) like, iTLC, and IPC. Experience with other analytical techniques (e.g., Wet Chemistry). 

• Proficiency in technical writing. 

• Experience with laboratory data management systems (LIMS) and electronic lab notebooks (ELN). 

• Adaptability to cross training in microbiology techniques such as bioburden and environmental monitoring. 

• Ability to interpret analytical data with high attention to detail focus on accuracy, quality, and compliance. 

• Strong analytical thinking with the ability to identify and resolve complex analytical chemistry challenges. 

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your