Manufacturing Process Expert

Your responsibilities include, but are not limited to:

• 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 on going self-learning and ensuring training is up to date.
• Provide guidance and support to production team through training and knowledge sharing.

• This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.
• This position may require shift work including weekends and off hours support.
• Strong interpersonal, written, communication skills along with problem solving and follow-up skills.
• Well organized, flexible and work with minimal supervision.

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
• 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.
• Good understanding of manufacturing and validation requirements and activities.
• Radiation safety education (desired).
• 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