Associate Director, Tech Transfer & Lifecycle Lead 80-100%

Lonza Group; Stein (AR); On-site; Vertraulich; Full time

Benefits offered by this job

Relocation assistance

Full benefits

Relocation support and global benefits

Job summary

Lonza in Stein, AG, Switzerland is seeking an Associate Director, Tech Transfer & Lifecycle Lead to own high-value Drug Product technology transfers and lifecycle programs. You will lead end-to-end activities from clinical development through process validation (PPQ), regulatory submissions and commercialization, ensuring GMP-ready operations.

You will mentor teams, collaborate with Manufacturing, MSAT, QA, Regulatory Affairs and Supply Chain across a global network, and drive continuous

Qualifications

• Extensive experience in biopharma/pharma/CDMO environments focusing on Drug Product tech transfer and lifecycle programs.
• Strong knowledge of aseptic processing, including biologics, lyophilization, prefilled syringes, sterilization and primary packaging.

Responsibilities

• Lead high-value Drug Product tech transfer and lifecycle programs from clinical development through CPV/OPV, regulatory submission, commercialization and lifecycle management.
• Act as senior technical authority for complex programs, defining commercialization and validation strategies, providing governance and escalation support.
• Lead transfer, scale-up and implementation of manufacturing processes into GMP operations with readiness for commercial launches.
• Develop Stage 1/2/3 validation strategies, PPQ execution, data analysis and post-approval change assessments.
• Collaborate with cross-functional teams (Manufacturing, MSAT, QA, QC, Regulatory, Supply Chain) to meet milestones and audits.
• Mentor Technology Transfer Leads and drive SOP and CPV harmonization across a global network.

Skills

Tech transfer

Process validation

Lifecycle management

Aseptic fill & finish

GMP compliance

Regulatory submissions

Job description

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. As Associate Director, Tech Transfer & Lifecycle Lead you take ownership of critical customer programs and play a pivotal role in bringing innovative products to market, leading technology transfers, commercial launches and lifecycle management activities within a state-of-the-art Drug Product fill & finish manufacturing facilities. You'll provide expert technical leadership, work in cross-functional teams and shape the processes, validation strategies and manufacturing standards that ensure successful product launches, sustained process performance and operational excellence. 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 dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.
• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits
• Our local benefits can be found here: 3cf206339e0e4e41a77e8c806138c2b5

What you will do:

Lead high-value and high-complexity Drug Product technology transfer and product lifecycle programs, driving the end-to-end journey from clinical development through process validation (PPQ), regulatory submission, commercialization, CPV/OPV and lifecycle management. Act as the senior technical authority for complex customer programs, defining commercialization and validation strategies, providing technical governance, and serving as the escalation point for critical manufacturing, process and compliance challenges. Lead the transfer, scale-up and implementation of Drug Product manufacturing processes into GMP operations, ensuring manufacturing readiness, successful commercial launch and sustainable routine production performance. Develop and oversee Stage 1, Stage 2 and Stage 3 Process Validation strategies, including risk assessments, PPQ execution, statistical evaluations, trend analysis, process monitoring and post-approval change assessments. Partner closely with customers and cross-functional stakeholders across Manufacturing, MSAT, QA, QC, Regulatory Affairs and Supply Chain to deliver program milestones, support regulatory submissions, and ensure inspection readiness for PAI and GMP audits. Mentor Technology Transfer Leads and MSAT experts while driving continuous improvement and harmonization of SOPs, validation standards, CPV frameworks and lifecycle management processes across a growing global manufacturing network.

What we are looking for:

Extensive experience in biopharma, pharmaceutical or CDMO environments, with deep expertise in Drug Product technology transfer, process validation and lifecycle management within aseptic fill & finish manufacturing. Strong technical knowledge of aseptic processing, including biologics, with experience in technologies such as lyophilization, prefilled syringes, sterilization processes and primary packaging. In-depth understanding of GMP, CMC and global regulatory requirements, with proven ability to support commercialization, regulatory submissions, validation activities and post-approval changes. Demonstrated success in leading complex technology transfer and commercial launch programs, influencing cross-functional stakeholders and driving strategic decisions in fast-paced manufacturing environments. Expertise in Stage 1, Stage 2 and Stage 3 Process Validation, including PPQ, CPV/OPV, process performance monitoring, statistical data analysis, trend evaluation and continuous process improvement. Excellent communication, stakeholder management and leadership skills, with the ability to mentor technical teams, navigate complex customer interactions and deliver impactful results across global and cross-site networks.

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.