Key Responsibilities:

• Provide real-time technical and procedural support to production technicians on the manufacturing floor
• Lead investigations for deviations, including Out Of Specification and Out Of Expectation results
• Collaborate cross-functionally to assess deviation impact and identify root causes
• Initiate and track CAPAs, ensuring timely resolution and effectiveness verification
• Identify and implement process and quality improvements with Manufacturing and Operational Excellence teams
• Analyze manufacturing data to detect process trends and escalate potential issues
• Escalate deviations according to guidelines and present details clearly, including root cause and CAPAs.
• Deliver targeted training and coaching to new team members and investigators
• Maintain inspection readiness and support internal and external audits

Essential Requirements:

• Bachelor’s degree required, preferably in a scientific discipline
• Minimum 3 years of previous GMP experience is required
• Proven background in the pharmaceutical industry with hands-on manufacturing exposure
• Demonstrated experience leading investigations and driving root cause analysis
• Strong understanding of deviation management, CAPA processes, and regulatory compliance
• Excellent communication and collaboration skills across cross-functional teams
• Technical writing skills

Desirable Requirements:

• Experience working in a radiopharmaceutical or radioligand therapy manufacturing environment
• Knowledge of Lean Six Sigma or other continuous improvement methodologies

Shift:  Wed-Sat, PM Shift (1-11:30pm).  Flexibility to work alternate shifts and overtime to support the business, as needed. 

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77,000 to $143,000/yearly. 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. To learn more about the culture, rewards and benefits we offer our people click here.

Company will not sponsor visas for this position.