Technical Transfer Operations Lead / Technical Transfer Operations Lead

Technical Transfer Operations Lead – 7094

Our client is a leading global player in the Pharmaceutical industry, headquartered in Basel, Switzerland. They are currently undergoing a transformation to enhance their culture and external perception. The organization focuses on innovative therapies in Oncology and Ophthalmology, while also developing a world-class pipeline in Neuroscience and Dermatology, boasting one of the strongest pipelines of Phase II/III studies globally.

We are seeking a qualified candidate for the position of Technical Transfer Operations Lead (TTO) to join our client's team.

Role Overview

The Technical Transfer Operations Lead (TTO) is responsible for managing technical transfer operations concerning combination products, medical devices, and secondary packaging implementation. The TTO establishes and carries out a cohesive technical transfer strategy for GDPD (Global Product Development) in alignment with NTO (New Technology Operations). This includes harmonizing cross-site manufacturing transfers from development stages to site level and coordinating development support for product maintenance operations, acting as a vital customer resource for NTO.

The TTO also supports and may serve as the Tech Transfer Lead in Device and Secondary Packaging activities, facilitating transfer and launch processes for assigned projects, and collaborating with project teams on device assembly and secondary packaging processes within the GDPD manufacturing network. Efficient communication with related global functions—particularly Device Development GDPD, TechOps, Regulatory Affairs, and Supply Chain—is critical. The TTO plays a key role in ensuring the successful launch and transfer of assembly and packaging processes from development to commercial operations, guaranteeing timely availability of launch supplies in required quantities.

This is a one-year contract position based in Basel, with a strong possibility for extension.

Main Responsibilities

• Manage technical transfer operations concerning combination products and medical device secondary packaging implementation.
• Provide expertise on combination product and medical device matters related to strategy, processes, technical issues, and e-systems during device development and commercialization.
• Establish and execute a cohesive technical transfer strategy for GDPD in collaboration with NTO while ensuring alignment of template-based documentation for design transfers.
• Coordinate development support for product maintenance (Lifecycle Management) as it pertains to NTO and manage teams to implement changes related to the medical device platform.
• Support and potentially lead Launch Site Decisions, as well as technical transfer and launch activities for assembly and packaging at relevant sites as a member of the GDPD Device Development Subteam.
• Assist the manufacturing representative during design control stages and in the assembly and packaging design processes for the GDPD product portfolio.
• Support internal and external audits on packaging and medical device-related matters.
• Prepare function-related documents for the registration of medical devices/combination products and provide responses to health authority inquiries.
• Take on additional responsibilities as mutually agreed upon through training.

Qualifications and Experience

• Relevant working/residency permit or Swiss/EU citizenship is required.
• PhD or Diploma in Mechanical Engineering or Pharmaceutical Technology.
• A minimum of 5 years of professional experience in Pharmaceutical Manufacturing, particularly in assembly and packaging or Manufacturing Science and Technology.
• Strong understanding of product processes, applied statistics, quality systems, and regulatory requirements across various health authorities.
• Fundamental knowledge of standard device and packaging analytical testing.
• Expertise in reviewing and writing technical reports.
• Strong project management skills.
• Excellent communication and intercultural skills, capable of working in a global matrix environment.
• Knowledge of 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).
• Familiarity with 21 CFR part 210/211, 21 CFR part 4/820, ISO 13485, ISTA, ASTM, and the EMA medical device directive.

Apply online using the form below. Please note that only applications matching the job profile will be considered.