The company is seeking an Associate Director for Technology Transfer to lead complex drug product transfers from development to commercial launch, focusing on aseptic fill&finish processes, based in Stein, Switzerland.
This position is central to transitioning advanced drug products from the development phase into full commercial production. The role oversees the complete technology transfer process, covering scale-up, process performance qualification, regulatory submissions, and final launch, with a specific emphasis on aseptic fill and finish operations. The role is based entirely on-site in Stein.
Responsibilities
- Direct the end-to-end commercial transfer of complex drug products, from initial introduction through process validation, regulatory filings, health authority inspections, and the first commercial batch.
- Serve as the global technical authority for process technology transfer, defining strategy, aligning standards across locations, and ensuring customer-focused excellence throughout the product lifecycle.
- Provide senior-level technical guidance and act as the escalation point for difficult manufacturing challenges, particularly for late-stage and commercial programs.
- Act as the main technical contact for manufacturing topics within project teams, defining scope, tracking progress, and managing timelines for assigned project stages.
- Oversee process setup, scale-up, and implementation at GMP manufacturing sites, providing on-site technical support during batch production.
- Manage new product introduction, process control strategies, technical transfer, and validation documentation, including reviewing dossier modules for regulatory submissions.
- Lead GMP change management strategies, initiate change controls, and support the resolution of critical deviations through corrective and preventive actions.
- Ensure all activities comply with Good Manufacturing Practice, Health, Safety, Environment, and regulatory standards.
Requirements
- Extensive experience in biotech, pharma, or CDMO settings, with deep expertise in drug product development and technology transfer, particularly in aseptic fill and finish processes such as lyophilization and prefilled syringes.
- Comprehensive understanding of GMP, regulatory, and CMC requirements, with the ability to translate strategic plans into effective manufacturing execution.
- Demonstrated success in leading complex manufacturing strategies and resolving high-impact technical issues across global, cross-site operations.
- Strong communication and stakeholder engagement skills, with the ability to influence senior leadership and navigate complex decision-making environments.
- University degree in Biochemistry, Pharmaceutical Science, or a related field (PhD preferred).
- Excellent project, risk, and data management skills, combined with clear technical writing abilities; fluent English is required, with German being advantageous.
Nice to have
What the company offers
- Relocation assistance is available for eligible candidates and their families, if needed.
- An agile career and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A competitive salary.
- Numerous lifestyle, family, and leisure benefits.
About the company
The company operates with core values of Collaboration, Accountability, Excellence, Passion, and Integrity, which guide how employees work together. They value diversity and are committed to creating an inclusive environment for all employees.
- Core values of Collaboration, Accountability, Excellence, Passion, and Integrity guide daily work.
- Commitment to diversity and an inclusive environment for all employees.
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