QC Chemistry Manager

Job Description Summary

Location: Carlsbad, California (on-site)

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with experience building teams in start-up environments to lead the QC Chemistry Lab at our new Carlsbad site.

As the QC Chemistry Manager, you will be responsible for overseeing the analysis of radiopharmaceutical drug products performed by QC analysts/technicians.

 

Job Description

Key Responsibilities:

• Management of QC Analytical activities in line with site objectives. Coordination of departmental Operational activities. Track team metrics and ensure KQI /KPI meet requirements.
• Lead OpEx Projects. Support transfer Projects and validation studies.
• New equipment commissioning Support (OQ, PQ). Ensure qualification /calibration status of analytical equipment.
• Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. SOP review and revision.
• Define improvement areas in process and products.
• Perform local training and monitor training status for Microbiological QC. Ensure training according to cGxP requirements.
• Ensure DI and compliance with cGxP and all regulatory requirements. Collaboration in GxP internal audits and ensure fulfillment of internal/external audit and inspection plans.
• Management of documentation and Methods according to cGxP.
• Ensure compliance of products and other materials with specifications and with corporate, health authorities, and E5 requirements
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Essential Requirements:

• BS in Analytical Chemistry or relevant scientific field
• 5 years of experience in a GMP quality control environment utilizing techniques such as HPLC, pH, bacterial endotoxins, radioactivity dose calibration, iTLC, etc.
•  2 years of experience in a people management role.

Desirable Requirements:

• Advanced degree

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24 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, …