Site Head MS&T/MS&T LT large site

Job Description Summary

-Site MSAndT Head-Medium/Small SiteLeads the Site’s MSAndT organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge and capabilities at the Site and to ensure the product and technical stewardship, across process units and functions at Site.Senior Technical Transfer LeadResponsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).Senior Product StewardOwns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.Senior Technical Steward / Senior Technical Manager MSAndTProvides 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.Senior Validation LeadResponsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.  

Job Description

Major accountabilities:

• Site MSAndT Head-Medium/Small Site -Set objectives and develops vision for department.
• Act as SPOC for site head and MSAndT platform/ cluster head.
• Manage the MSAndT career path, succession planning, training program and career progression within the site.
• Enable knowledge management for processes and products within department and across site functions.
• Reporting acc.
• to QM, NTO LT, quality cockpit, Global MSAndT.
• Ownership of the site Validation Master Plan (VMP) (creation and maintenance).
• Ensure that execution of VMP activities are trackedSenior Technical Transfer Lead -(Multi-site) launch transfers; bulk and combination product transfers -Transfer of portfolio products (e.g. site exit) -complex transfers (ESO, new technologies / equipment) -support launch readiness -support BDAndL evaluationsSenior Product Steward -For x-site products: Product centric, APQR, coordination of change management, issues, LCM projects, lessons learned, support to SPL / LCM group, improvement projects: keeping key brand team updated on production schedule, informing on issues, changes, improvements -Owns the process knowledge of site brands, managing x-site products, managing complex blockbuster brands, large TLCM projects involving multiple sites, acting as network SPOC for SPL, as well as ensuring seamless flow of knowledge and information across functions, and with other Sites when applicable.
• Senior Technical Steward / Senior Technical Manager MSAndT -Managing Technology at network level and NTO SPOC for non-NTO organizations -Sound expertise across different technologies (e.g. tableting, coating, granulation, media fills, CCIT, viral clearance studies, L/E, cell banking etc) -Cross site new technology implementationSenior Validation Lead -Manages large validation team and large, complex product portfolio, high number of launch validations and embarks on new validation concepts for new technologies -Establishes standardization for validation across platforms / NTO -Providing senior expertize on complex process validation topics (e.g. Viral clearance, resin reuse) -Managing validations of several projects in large multiproduct sites -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Cost, C-Sat and productivity targets -Achievement of project plans & milestones -Internal customer satisfaction with quality of services provided -Succession plan for MS&T in place and robust.
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Minimum Requirements:
Work Experience:

• Fix-its/Turnarounds.
• Functional Breadth.
• People Leadership.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Applied Statistics.
• Assembly Language.
• Back-End Development.
• Biotechnology.
• Chemical Engineering.
• Chemistry.
• Design Development.
• Electronic Components.
• General Hse Knowledge  .
• Incentive Program.
• Including Gdp.
• Knowledge Of Capa.
• Knowledge Of Gmp.
• Leadership.
• Manufacturing (Production).
• Manufacturing Process.
• Manufacturing Technologies.
• Npd (New Product Development).
• Process And Cleaning Validation.
• Process Control.
• R&D (Research And Development).
• Root Cause Analysis (Rca).
• Software Development.
• Software Engineering.
• Technical Leadership.
• Technology Transfer.

Languages :

• English.

Skills Desired

Change Management, Manufacturing Process Science, Manufacturing Production, Manufacturing Technologies, Process Control, Process Simulation, Quality Compliance, Technical Leadership, Waterfall Model