QC Chemist

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 compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.