Associate Director, Technology Transfer 80-100%

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza is seeking an Associate Director, Technology Transfer (Global MSAT) to drive end-to-end drug product transfers from development to commercial launch. You will guide scale-up, PPQ, regulatory filings, and inspections with a focus on aseptic fill-finish processes.

The role is site-based, emphasizing in-person collaboration and high technical precision to manufacture medicines to the highest quality and safety standards. English required; German a plus.

Qualifikationen

• Experience in biotech/pharma/CDMO environments with tech transfer focus.
• Deep knowledge of GMP, regulatory, and CMC requirements.
• Ability to influence and lead complex manufacturing strategies.
• Strong communication and stakeholder engagement skills.
• PhD preferred in Biochemistry or Pharmaceutical Science.
• Excellent project, risk, and data management with clear technical writing.

Aufgaben

• Lead high-complexity technology transfers from development to commercial launch.
• Act as global SME for Process Technology Transfer and standard alignment.
• Provide technical leadership for late-phase and commercial programs.
• Serve as primary technical contact for technology-transfer topics within teams.
• Oversee process setup, scale-up, and GMP manufacturing site support.
• Drive documentation for regulatory filings and dossier reviews.
• Lead GMP change management and CAPA implementation.
• Ensure compliance with GMP, HSE, and regulatory standards.

Kenntnisse

Biotech/pharma exp

Tech transfer

Aseptic fill-finish

GMP knowledge

Regulatory knowledge

CMC knowledge

Leadership

Stakeholder engagement

Technical writing

English proficiency

Ausbildung

PhD in Biochemistry/Pharmaceutical Science

Jobbeschreibung

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Join Lonza as an Associate Director, Technology Transfer (Global MSAT) and play a pivotal role in bringing complex drug products from development to commercial reality. You'll lead end-to-end technology transfers -from process scale-up and PPQ to regulatory filings, inspection readiness, and successful launch with a focus on aseptic fill&finish processes.

Check out Your Career in Drug Product Services at Lonza !

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and a dynamic work culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

What you will do:

• Manage, drive and guide high-complexity and high-impact drug product commercial transfers from New Product Introduction to PPQ, regulatory filing, pre-approval health authority inspections and first commercial launch.

• Act as global Subject Matter Expert for Process Technology Transfer, shaping technical strategy, ensuring global standard alignment, and driving customer-centric excellence across sites and product lifecycles.

• Provide technical authority and act as senior escalation point for complex technical challenges, provide tech transfer leadership for late-phase and commercial programs.

• Serve as the primary technical point of contact for all technology-transfer-related manufacturing topic of assigned projects within internal and customer project teams. Define and monitor project scope, timing and progress of assigned stages.

• Lead process setup, scale-up, and implementation activities at GMP drug product manufacturing sites, including on-site technical support during batch execution.

• Responsible for new product introduction, process implementation, process control strategy and technical transfer and process validation documentation of assigned projects, including review of dossier modules for regulatory filing.

• Drive GMP change management strategy of assigned projects as well as initiate and manage GMP change control in system. Lead and support critical GMP product / process deviations and corresponding implementation of corrective/preventive actions (CAPAs).

• Ensure all activities are performed according to current standards (Good Manufacturing Practice, Health Safety Environment, Regulatory etc.).

What we are looking for:

• Industry-leading expertise in biotech/pharma/CDMO environments, with strong experience in drug product development, tech transfer especially within aseptic fill&finish processes (e.g. lyophilization, prefilled syringes). Proven ability to translate scientific depth into strategic decision-making.

• Deep knowledge of GMP, regulatory, and CMC requirements, with the ability to translate strategy into robust manufacturing execution

• Proven ability to influence and lead complex manufacturing strategies and resolve high-impact technical challenges across global, cross-site operations

• Strong communication and stakeholder engagement skills, influencing senior leaders and navigating complex decision-making environments

• University degree in Biochemistry, Pharmaceutical Science or similar field (PhD preferred)

• Excellent project, risk, and data management capabilities, paired with clear technical writing; fluent in English (German is a plus)

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences?