Production Manager

3 weeks ago

Carlsbad CA, United States Novartis Group Companies Full time

Job Summary:

We are seeking an experienced Production Manager to lead our manufacturing operations unit in achieving site objectives in areas such as Safety, Supply, Cost, Quality, and People for a GMP Radioligand Therapies Production Facility.

The successful candidate will identify and implement the necessary programs and actions to ensure sustainable and reliable execution of manufacturing operations in alignment with cGMP regulatory expectations at the Carlsbad Site.

Key Responsibilities:

  • Responsible for the daily operations and efficient utilization of resources to meet processing demands.
  • 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.
  • Interview and hire production staff in conjunction with other functions and/or Head of Production.
  • 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.
  • Help promote an unbossed culture supporting ownership, innovation, speak-up, and accountability.

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.
  • ~ 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.
  • ~ 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.

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.

We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.

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