Technical Transfer Operations Lead (7094)

CTC Resourcing Solutions AG; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions AG is seeking a Technical Transfer Operations Lead (TTO) for a Basel-based role, initially a 1-year contract. The TTO will oversee technical transfer operations for combination products, medical devices and secondary packaging, aligning templates and documentation for design transfers to NTO, and coordinating global transfers.

Ideal candidates hold a PhD in Mechanical Engineering or Pharmaceutical Technology, with 5+ years in pharmaceutical manufacturing, plus strong

Qualifikationen

• PhD in Mechanical Engineering or Pharmaceutical Technology.
• Residence permit or Swiss/EU citizenship required.

Aufgaben

• Own technical transfer operations for combination products, medical devices and secondary packaging.
• Provide platform expertise during device development, commercialization and for commercial products.
• Establish and harmonize an aligned technical transfer strategy for GDPD with NTO across development to site level.
• Coordinate development support of product maintenance and manage teams for changes to the medical device platform.
• Support launch site decisions and transfer/launch activities for assembly and packaging at involved sites.

Kenntnisse

Project management

Communication

Intercultural skills

Regulatory knowledge

Quality systems

Ausbildung

PhD in Mechanical Engineering or Pharmaceutical Technology

Residence permit / Swiss-EU Citizenship

Jobbeschreibung

Technical Transfer Operations Lead – 7094

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

For our clients team, we are seeking a suitable candidate for a Tech Transfer Operations Lead (TTO) position.

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. The TTO establishes and upholds aligned template based documentation for design transfers to NTO. The TTO 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.

This role is 1 year contract with high chances of extension to be based in Basel.

Main 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 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.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• PhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology
• 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.