Key Responsibilities:

Responsibilities include but not are limited to:

• 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. Establish and maintain Production unit in full GMP and HSE compliance
• 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.
• Support compliance activities including deviations, CAPAs, Investigation and OOS and OOT
• Interview and hire production staff in conjunction with other functions and/or Head of Production.
• Implement cost control programs or procedures.
• Audit and review emergency paperwork and processes to ensure compliance.
• Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demands.

• Establish and optimize training programs for manufacturing.
• Assist in preparation for commercial launch, including commissioning and qualification of rooms and equipment. 
• Ensure and maintain qualified status of production equipment and methods for intended use in Production lines; Ensure adequate management of Production related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
• Prepare for and participate in Health Authority inspections and internal audits; Ensure Production personnel are duly qualified, and manufacturing is properly conducted and documented for all performed activities; Evaluate and approve Production records as required and manage the staff objectives, performance, and development.
• Analyze Key Performance Indicators with a statistical mindset to identify opportunities for improvement.
• Collaborate with supply chain organization to plan production and deliver 100% On-Time-In-Full deliveries.
• Perform analysis of trends in deviations and other events and facilitate resolution defining action plans.
• Follow-up on actions to ensure timely execution; Help promote an unbossed culture supporting ownership, innovation, speak-up, and accountability.

Job Dimensions:

Number of associates:

Direct: 3-5 associates

Financial responsibility:

(Budget, cost, sales, etc.)

Manufacturing OPEX budgets.

Responsible for drug product COGS >US $1 million.

Working Conditions:

• Ensures reliable and compliant operations. Improves outcome in regulatory inspections.
• On-site with daily presence in a pharmaceutical laboratory and manufacturing facility.

Essential Requirements:

• BS degree in life sciences, engineering, chemistry, biotechnology, or related field or equivalent relevant experience
• Training in radiochemistry or radio pharmacy is an preferred
• 4 or more years’ experience in GMP operational roles with direct experience in pharmaceutical manufacturing, specifically low bioburden manufacturing preferred, 3+ years of leadership experience.
• Involvement with quality regulatory inspections of facilities from major agencies such as FDA or EMA.
• Shows the appropriate sense of urgency around given tasks
• Strong change management skills, adaptability, and the ability to work under pressure.
• Proficient technical writing skills.
• Proven ability to plan and manage operational process for maximum efficiency and
• Good understanding of manufacturing and validation requirements and activities.
• Radiation safety education (desired).
• Strong leadership skills (communication, cross-functional teamwork, drive to enable problem solving).
• Leverage new technologies and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve