TECHNICAL MANAGER

Summary The Technical Manager role in External Supply Operations business unit belongs to the manufacturing Science and Technology functional area which covers Novartis products made at Contract Manufacturing Organizations.
In this role you will own the knowledge of specific pharmaceutical process technologies for the Novartis products under responsibility and collaborate effectively with other involved functions (e.
.
Technical Research & Development (TRD), Supply Chain Operations, Quality, Production, Regulatory, HSE and others), both internal or external at the Contract Manufacturing Organization (CMO).
About the Role Deadline for applications.
28th of July, .
Major accountabilities.
Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
Technical Transfer Lead, review first APQR after transfer to ensure adequate product performance, ensure all relevant technical information and documentation for validation is available.
Review APQR and decide on state of control.
Define pre-validation / validation strategy including process, cleaning, packaging and supportive studies (e.
., hold times).
Act as Validation Lead / Validation Expert in creation of validation protocol and report, maintaining the process control strategy.
Coordinate technical, regulatory and validation batches at site.
Product Steward, maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
Technical Steward - Acting as SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
Harmonize and optimize technical processes across the site.
Provide technical expertise for validation activities around technologies within area of responsibility.
Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
Senior Scientist MS&T, managing complex projects with deep understanding of development process requirements, participating in root cause investigations.
New by-product investigation, complex deviations.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Contributing to improvement of following KPIs.
Product Unit Cost, achievement of project plans & milestones, ensuring completeness of Validation Master Plan (VMP), Manufacturing Robustness Review (MRR).
Minimum Requirements.
Education.
Scientific Degree in Pharmaceutical studies or equivalent/similar such as, Chemistry, Chemical Engineering.
5-10 years of experience in similar role within Pharmaceutical industry, special focus on tech transfer, API changes, demonstrated expertise in manufacturing processes for oral solids technologies.
Team player with strong problem solving skills, collaborative approach and proactive self-starter approach, able to coordinate technical investigations.
Experience working and navigating in a crossfuctional matrix organization and able to work autonomously.
Fluent English, written and spoken.