Tech Transfer Operations Lead- Pharmaceutical Manufacturing

RM IT Professional Resources AG; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

RM IT Professional Resources AG Basel is seeking a Tech Transfer Operations Lead to drive technical transfers for combination products and medical device packaging. You will align transfer strategy with GDPD and coordinate跨-site manufacturing transfers from development to site level, supporting design transfer docs to NTO.

You will lead project teams in device assembly and packaging processes, liaise with global functions, and ensure successful launches and on-time launch supplies across sites.

Qualifikationen

• PhD or Dipl. Ing. level in Mechanical Engineering or Pharmaceutical Technology.
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Aufgaben

• Coordinate technical transfer operations for combination products and secondary packaging.
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Kenntnisse

PhD/Dipl. Ing. level

Project management

Communication skills

Design control knowledge

Regulatory knowledge

Ausbildung

PhD or Dipl. Ing. in Mechanical Eng / Pharmaceutical Tech

Jobbeschreibung

Tech Transfer Operations Lead vacancy for our Basel based client in the Pharma sector.

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).

Your tasks:

1. Responsible for technical transfer operations regarding combination products/medical device & secondary packaging implementation.
2. 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.
3. 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.
4. Coordinate development support of product maintenance (LCM) for NTO as a customer and manage teams to implement changes concerning the medical device platform.
5. 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.
6. Support the manufacturing representative during device development stages (design control) and in the assembly and packaging design process for the GDPD product portfolio.
7. Support internal & external audits on packaging and medical devices related matters.
8. Drive preparation of the function related documents (sections) for registration of medical device/combination products and provide input to health authority questions.
9. 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.
• Language skills: English - fluent; Other languages beneficial

Location: Basel, Switzerland

Work setting: On Site

Sector: Pharma

Start: 01/10/2026

Duration: 12 months

Workload: 80%

Ref.Nr.: BH 24613

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.