Tech Transfer Operations Lead

SThree Germany; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

SThree Germany is seeking a Tech Transfer Operations Lead based in Basel, Switzerland. The role is fully on-site for a 12-month contract, focusing on technical transfer operations for combination products, medical devices, and secondary packaging.

The ideal candidate has 5+ years in pharmaceutical manufacturing, with deep knowledge of regulatory requirements and design control. You will drive aligned transfer strategies across GDPD and coordinate multi-site transfers with cross-functional teams.

Qualifikationen

• Minimum 5 years professional experience in Pharmaceutical Manufacturing (assembly & packaging) or Manufacturing Science & Technology.
• Strong understanding of product processes and regulatory requirements across multiple health authorities.
• Fundamental understanding of device/packaging analytical testing.
• Expert in reviewing and writing technical reports.
• Strong project management and cross-functional collaboration skills.
• Excellent communication and intercultural collaboration in a global matrix environment.

Aufgaben

• Lead technical transfer operations for combination products, medical devices, and secondary packaging.
• Provide strategic input on technical transfer and process topics during development and commercialization.
• Coordinate cross-site manufacturing transfers from development to site level with template-based documentation.
• Manage product maintenance changes and liaise with GDPD, NTO, and external audits.
• Support design control activities and packaging design processes within the GDPD portfolio.
• Act as deputy or Transfer Team lead in launch site decisions and transfer activities.

Kenntnisse

Project management

Communication

Intercultural skills

Statistical analysis

Jobbeschreibung

Tech Transfer Operations Lead

Location: Basel, Switzerland (fully on-site role)

Duration: 12-month contract

Languages: English - fluent; other languages - advantageous.

Position Overview:

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.

Responsibilities:

• 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 e-systems 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.

KPIs

• Aligned processes and harmonized documentation across sites for combination product/medical device platform


• Degree of standartization of production processes across-sites and products


• Aligned template-based documentation for design transfers to NTO


• Process robustness based on statistical evaluation


• No delay of milestones - supports meeting of agreed launch schedule.


• No critical observations during internal GMP inspections and pre-approval inspections (PAI).


• Action plans from internal audits implemented; no delays in approvals.

Education & Experience

• 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.


• Languages: Fluent oral and written English


• Candidates must hold a valid Swiss work permit or Swiss/EU passport