Manufacturing Process Expert

Novartis • Carlsbad, CA

406d

About The Position

The Manufacturing Process Expert plays a crucial role in supporting production activities within a pharmaceutical manufacturing environment. This position is responsible for ensuring compliance with cGMP and SOPs, providing training to production staff, managing documentation, and leading continuous improvement initiatives. The expert will also investigate deviations, manage change controls, and ensure that processes are always inspection-ready, contributing to the overall safety and quality of product batches.

Requirements

• BS degree in life sciences, engineering, chemistry, biotechnology, or related field or equivalent relevant experience.
• 4 or more years' experience in GMP operational roles with direct experience in pharmaceutical manufacturing, specifically low bioburden manufacturing preferred.
• 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.
• Good understanding of manufacturing and validation requirements and activities.

Nice To Haves

• Training in radiochemistry or radio pharmacy is preferred.
• Radiation safety education (desired).

Responsibilities

• Support a culture of safety, quality, diversity, and inclusion.
• Provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends.
• Identify, assess, and own technical changes through GMP change control processes.
• Investigate deviations and determine root causes and identify CAPA.
• Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.
• Ensure processes are inspection ready at all times.
• Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.
• Support validation protocol generation and execution.
• Support ongoing self-learning and ensuring training is up to date.
• Provide guidance and support to production team through training and knowledge sharing.

Benefits

• Diversity and Inclusion initiatives
• Professional development opportunities
• Health and wellness programs
• Flexible work arrangements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree