Technical Transfer Operations Lead - 7094

CTC Resourcing Solutions; Basel; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Zusammenfassung

The Tech Transfer Operations Lead (TTO) role is based in Basel and focuses on technical transfer operations for combination products, medical devices and secondary packaging within the GDPD network. You will harmonize cross-site transfers from development to site level and support device assembly and packaging launches. We seek a PhD or Dipl.

Ing. in Mechanical Engineering or Pharmaceutical Technology with at least 5 years in pharma manufacturing, strong regulatory knowledge, and proven ability

Qualifikationen

• PhD or Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology.
• Minimum 5 years of professional experience in pharmaceutical manufacturing / packaging.
• Strong understanding of regulatory requirements and quality systems across health authorities.
• Knowledge of design control, documentation, risk management and related processes.

Aufgaben

• Technical transfer operations for combination products, medical devices and secondary packaging.
• Provide expertise for strategy, process, technical and systems topics during development and commercialization.
• Establish and execute transfer strategy and harmonize cross-site manufacturing transfers.
• Coordinate development support of product maintenance and manage teams to implement changes.
• Lead or deputize transfer and launch activities for device assembly and packaging across sites.
• Support audits on packaging and medical devices; contribute to registrations and health authority responses.
• Prepare function-related documents for regulatory submissions and product registrations.

Kenntnisse

Technical transfer operations

Pharmaceutical manufacturing

Design control

Quality systems

Regulatory requirements

Cross-functional collaboration

Project management

Statistical methods

Documentation writing

Device Master Record (DMR)

Ausbildung

PhD or Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology

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 organization 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 deputize the TTO Group Head.

This role is a 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 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.

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 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.