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Tech Transfer Operations Lead-Pharmaceutical Manufacturing
Posted 3 hours 15 minutes ago by RM IT Professional Resources AG
Tech Transfer Operations Lead - Pharmaceutical Manufacturing, vacancy for our Basel based client in the Pharma sector.
Your tasks:
- Lead technical transfer operations for combination products, medical devices and secondary packaging implementation.
- 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.
Your experience/knowledge:
- Degree at PhD or Dipl. Ing. level in Mechanical Engineering, Pharmaceutical Technology, or a related field.
- 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.
- Strong knowledge of design control, risk management, documentation processes, and medical device/combination product requirements.
- Language skills: English - fluent
Location: Basel, Switzerland
Work setting: On Site
Sector: Pharma
Start: 01/10/2026
Duration: 12 months
Workload: 80%
Ref.Nr.: BH 24613
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, and current work-permit holders for Switzerland.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
RM IT Professional Resources AG
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