Key responsibilities

• Responsible for the daily operations and efficient utilization of resources to meet processing demands
• Ensure the products are produced, inspected, stored and released in accordance with approved procedures.
• Support shop floor trouble shooting and problem solving as needed
• Responsible for authoring, reviewing and/or approving GMP documents including but not limited to SOPs, Batch Records, Labels, Protocols, Reports, Validation documents.
• Ensure Good Documentation Practice are followed on the shop floor.
• Ensure production team receives complete cGMP training and are qualified to perform the required operations.
• Author and support compliance activities including deviations, CAPAs, Investigation and OOS and OOT. Audit and review emergency paperwork and processes to ensure compliance.
• Interview and hire production staff in conjunction with Production Management.
• Implement cost control programs or procedures
• Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demand.

Essential Requirements:

• Bachelor’s degree in relevant Engineering or Scientific discipline or equivalent experience plus 4 years’ relevant experience with aseptic pharmaceutical manufacturing, including prior leadership experience. 
• Knowledge and understanding of cGMP requirements and the application of continuous improvement in a regulated environment.
• Demonstrated history of working collaboratively across functions and sites.
• Strong leadership, communication and analytical/problem solving skills.
• Change management, adaptability, and ability to work under pressure.
• 5-10% travel

Desirable Requirements:

• Prior experience or training in radiochemistry or radiopharmaceuticals.

Shift: This role is Wed-Sat, AM Shift (6am-6pm, 12-Hour Shifts, alternating Wednesday’s).

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $201,500/per 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. To learn more about the culture, rewards and benefits we offer our people click here.

Company will not sponsor visas for this position.