Technical Transfer Operations Lead (TTO)

WillHire; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Magnit Global seeks a Tech Transfer Operations Lead to support GDPD with NTO across the Novartis manufacturing network. The role focuses on technical transfer operations for combination products, device packaging, and template documentation to enable smooth launches and transfers from development to site operations.

The candidate will coordinate cross-site activities, contribute to design control documentation, support audits, and work with global functions.

Qualifikationen

• PhD or Diploma in Mechanical Engineering or Pharmaceutical Technology.
• Fluent English and local language; other languages beneficial.
• At least 5 years of experience in pharmaceutical manufacturing or related MT/technical development.
• Strong knowledge of statistics, quality systems and regulatory requirements.
• Experience with device/packaging design control and documentation.
• Project management and cross-cultural communication skills.
• Knowledge of 21 CFR Part 210/211, 4/820, ISO13485, EMA directives.

Aufgaben

• Oversee technical transfer operations for combination products and packaging.
• Provide expertise on device development for transfers from development to site operations.
• Develop and harmonize template documentation for design transfers to NTO.
• Coordinate development support of product maintenance (LCM) for NTO.
• Lead transfer and launch activities at involved sites; member of GDPD Device Development Sub Team.
• Support design control activities and packaging design processes.
• Assist internal and external audits related to packaging and medical devices.
• Contribute to regulatory submissions and responses.

Kenntnisse

English fluency

Project management

Communication skills

Intercultural skills

Design control knowledge

Regulatory knowledge

Quality systems knowledge

Ausbildung

PhD or Diploma in Mechanical Engineering or Pharmaceutical Technology

Jobbeschreibung

This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

This role is offered through Magnit Global, who, if selected, will be your employer. If your services are retained, you will be assigned to provide services to Novartis as the end client. This is not an offer of employment with Novartis. If you are selected for this Temporary/External opportunity, you will not be an employee of Novartis and will not be eligible for any Novartis employee benefits or incentives.

Ready to work with/through Magnit at Novartis? Please read on…

Job Purpose:

The Tech Transfer Operations Lead (TTO) is responsible for technical transfer operations regarding combination products/medical device & secondary packaging implementation. The TTO establishes and executes an aligned technical transfer strategy for GDPD with NTO and harmonizes cross-site manufacturing transfers from development to site level and the coordination of development support of product maintenance operations for NTO as a customer. He establishes and upholds aligned template based documentation for design transfers to NTO. He supports but can also act as the TTL (Tech Transfer Lead) in Device & Secondary Packaging activities related to transfer and launch for assigned projects as well as project teams for device assembly and secondary packaging processes within the GDPD manufacturing network. Liaises efficiently with related global functions, in particular Device Development GDPD, TechOps, Regulatory and Supply Chain. Is supporting successful launch / transfer of assembly and packaging processes from Development into Commercial operations and for the availability of launch supplies (in time and in required quantities). TTO can act as deputy within the TTO team and can also deputise the TTO Group Head.

Major Accountabilities:

• Responsible for technical transfer operations regarding combination products/medical device & secondary packaging implementation.
• Provide expertise from combination product/medical device platform point of view for strategical, process, technical, and esystems related topics during device development, commercialization and for commercial products.
• Establish and execute an aligned technical transfer strategy for GDPD with NTO and harmonizes cross-site manufacturing transfers from development to site level including alignment and upholding of template-based documentation for design transfers to NTO.
• Coordinate development support of product maintenance (LCM) for NTO as a customer and manage teams to implement changes concerning the medical device platform.
• Support but can also act as Transfer Team lead in Launch Site Decisions and in technical transfer and launch activities for assembly and packaging at involved sites and is member of the GDPD Device Development Sub Team.
• Support the manufacturing representative during device development stages (design control) and in the assembly and packaging design process for the GDPD product portfolio.
• Support internal & external audits on packaging and medical devices related matters.
• Drive preparation of the function related documents (sections) for registration of medical device/combination products and provide input to health authority questions.
• Additional mutually agreed roles defined by trainings assigned.

Requirements:

• PhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology
• Fluent in English and local language. Other languages beneficial
• Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects.
• Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Fundamental understanding of standard device/packaging analytical testing.
• Expert in reviewing and writing technical reports.
• Strong Project management skills.
• Strong communication and intercultural skills with ability to work in a global matrix environment.
• Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications).
• Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive.

Workload:80-100%

Role type: Onsite

Required start date: October 2026

Contract: 12 months

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?

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation:

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [e-mail].