Summary

•Subject Matter Expert of specific pharmaceutical processes, having a complete understanding of them and assuring a seamlessly operation of the Manufacturing Science and Technology (MS&T) strategies and objectives.
•Represents the main technical interface between Novartis and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness.
•Performs the technical due diligence in pre-evaluation phase to select the appropriate external suppliers together with BD&L.
•Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy products as well as new development products from Novartis to external suppliers or between external suppliers. Aligns with the Development organization for manufacturing process design during early-stage development

•Acts as the MS&T representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, AS&T Managers, Life Cycle Managers , Supply Chain Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and
information transfer within the organization and across functions with focus on process and product know-how.

About the Role

Major accountabilities:

- Responsible 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.).

- Owns 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).

- Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies when applicable.

- Responsible 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 aligned with Regulatory Authorities' expectations and related SOPs.

- Design, plan, perform, interpret and report scientific experiments under the lead of the department head to contribute to overall MS&T strategies and objectives.

Scientist MS&T

• Complex projects with deep understanding of development process requirements
• Difficult to solve topics (eg. new by-product investigation, complex deviations)
• Cross product alignment in support approach (larger 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)

Education:

• Higher scientific degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific field.

Languages:

• Fluency in English languages.
• undefined

Experience:

• Minimum 5 years of experience in pharmaceutical (chemical) manufacturing and in sterile drug product manufacturing , with a comprehensive know-how in pharmaceutical technology

Compentency

• Applied Business Insights
• Operational Excellence
• Project Excellence
• Manufacturing Process/Product Expertise

Key performance indicators:

• Cost, C-Sat and productivity targets
• Achievement of project plans & milestones
• Internal customer satisfaction with quality of services provided

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