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 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 pay range for this position at commencement of employment is expected to be between $81,200 and $150,800 /year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.