Job Description

Summary Provides to the Site the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies (e.g. Technical Steward for galenics, for film coating, biologics - upstream or downstream, etc.).
Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Key Responsibilities:

• Act as the 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.
• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
• Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
• Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
• Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
• Maintain their work in inspection readiness level.
• Support Product Stewards in creation of Quality Risk Assessments.
• Support creation of SOPs for Process Unit.
• Provide technical expertise to Engineering for design activities in Capex projects around technologies within area of responsibility.
• Provide technical expertise for equipment qualification around technologies within area of responsibility.
• Approve validation reports under their area of responsibility (as needed) e.g. packaging validation.
• Provide technical expertise for validation activities around technologies within area of responsibility.
• SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production.

Essential Requirement:

• Minimum 8-year experience in GMP manufacturing relevant to the specialist area of expertise.
• Proven process understanding (Pharma, GMP, Regulatory aspects).

Desirable Requirement:

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
• Desirable MSc. or equivalent experience.

Skills Desired Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer

Skills Required