Tech transfer lead

Proclinical Staffing; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a Technical Transfer Lead to drive transfer operations for combination products and medical device packaging in Basel. You will coordinate development support, lead launch decisions, and ensure alignment across development and manufacturing teams.

The role emphasizes regulatory submissions, audit support, and robust documentation to facilitate lifecycle management and compliant production of innovative products.

Qualifikationen

• Advanced degree in Mechanical Engineering, Pharmaceutical Technology, or related field.
• Proficiency in English; additional languages are a plus.
• Extensive pharmaceutical manufacturing and assembly/packaging experience.
• Strong knowledge of design control documentation and regulatory requirements.
• Excellent project management and cross-cultural communication skills.
• Experience reviewing and writing technical reports.

Aufgaben

• Oversee technical transfer operations for combination products and medical device secondary packaging.
• Provide expertise on combination product and medical device platforms during development, commercialization, and lifecycle management.
• Develop and execute aligned technical transfer strategies, including harmonized documentation for design transfers.
• Coordinate development support for product maintenance and manage teams implementing changes to medical device platforms.
• Act as a Transfer Team Lead for launch site decisions and technical transfer activities related to assembly and packaging.
• Assist with internal and external audits on packaging and medical device-related matters.
• Prepare function-related documents for regulatory submissions and respond to health authority inquiries.
• Perform additional responsibilities as mutually agreed upon and assigned.

Kenntnisse

English proficiency

Pharmaceutical manufacturing

Technical transfer

Project management

Regulatory understanding

Cross-cultural communication

Technical report writing

Ausbildung

Advanced degree in Mechanical Engineering

Advanced degree in Pharmaceutical Technology

Jobbeschreibung

Join a team where your expertise in technical transfer, medical devices, and pharmaceutical manufacturing will directly support the launch of life-changing products.

Proclinical is seeking a Technical Transfer Lead to support technical transfer operations for combination products and medical device secondary packaging implementation. In this role, you will play a key part in ensuring the successful transfer of processes from development to commercial manufacturing, while collaborating with cross-functional teams to maintain alignment and efficiency. This position offers an exciting opportunity to contribute to the launch and lifecycle management of innovative pharmaceutical products.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities

• Oversee technical transfer operations for combination products and medical device secondary packaging.


• Provide expertise on combination product and medical device platforms during development, commercialization, and lifecycle management.


• Develop and execute aligned technical transfer strategies, including harmonized documentation for design transfers.


• Coordinate development support for product maintenance and manage teams implementing changes to medical device platforms.


• Act as a Transfer Team Lead for launch site decisions and technical transfer activities related to assembly and packaging.


• Assist with internal and external audits on packaging and medical device-related matters.


• Prepare function-related documents for regulatory submissions and respond to health authority inquiries.


• Perform additional responsibilities as mutually agreed upon and assigned.

Key Skills and Requirements:

• Advanced degree in Mechanical Engineering, Pharmaceutical Technology, or a related field.


• Proficiency in English; additional languages are a plus.


• Strong experience in pharmaceutical manufacturing, particularly in assembly and packaging processes.


• Solid understanding of product processes, applied statistics, quality systems, and regulatory requirements.


• Expertise in reviewing and writing technical reports.


• Strong project management, communication, and intercultural skills.


• Knowledge of design control documentation, risk management, and processes such as DMR, DHF, pFMEA, and URS.


• Familiarity with relevant regulations, including 21 CFR parts 210-211, 21 CFR parts 4-820, ISO 13485, ISTA, ASTM, and EMA medical device directives.