Manufacturing Specialist (weekend day shift)

Major accountabilities:

• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.• Authoring/Owning investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
• Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.
• Participation in assigned qualification/validation activities, as necessary.
• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed.
• Prepares applicable documents and records such as batch records, shipping documents, and training materials.
• Participates in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned, as necessary.
• Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements:

• Bachelors degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
• Training in radiochemistry or radio pharmacy is preferred.
• 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Strong awareness of quality issues. Compliance investigations experience required.
• Good understanding of manufacturing and validation requirements and activities.
• Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards