Senior Tech Transfer & Lifecycle Lead — Drug Product

Lonza; Schweiz; On-site; Vertraulich; Full time

Benefits offered by this job

Agile career and dynamic working

Inclusive and ethical workplace

Compensation programs recognizing high

Benefits dependent on role and locale

Job summary

Lonza is seeking an Associate Director, Tech Transfer & Lifecycle Lead to own critical customer programs and guide technology transfers, validation strategies and lifecycle management in aseptic fill & finish manufacturing. This is a site-based role in Stein, AG, Switzerland with relocation options for eligible candidates.

You will lead end-to-end drug product tech transfer from clinical development through PPQ, regulatory submissions, and commercialization, while mentoring teams and ensuring

Qualifications

• 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 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.

Responsibilities

• Lead high-value and high-complexity Drug Product technology transfer and product lifecycle programs from clinical development through PPQ, regulatory submission, commercialization, CPV/OPV and lifecycle management.
• Act as senior technical authority for complex customer programs, defining commercialization and validation strategies, providing technical governance, and serving as escalation point for manufacturing, process and compliance challenges.
• Lead 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 1–3 Process Validation strategies, including risk assessments, PPQ execution, statistical evaluations, trend analysis, process monitoring and post-approval change assessments.
• Partner with customers and cross-functional stakeholders to deliver 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.

Skills

Biopharma experience

Technology transfer

Process validation

Lifecycle management

Aseptic fill & finish

GMP/CMC

Regulatory submissions

Job description

Lonza is seeking an Associate Director, Tech Transfer & Lifecycle Lead to own critical customer programs and guide technology transfers, validation strategies and lifecycle management in aseptic fill & finish manufacturing. This is a site-based role in Stein, AG, Switzerland with relocation options for eligible candidates.

You will lead end-to-end drug product tech transfer from clinical development through PPQ, regulatory submissions, and commercialization, while mentoring teams and ensuring