Senior Tech Transfer & Lifecycle Lead - Drug Product

Lonza Group

Stein (AR)

On-site

Vertraulich

Full time

5 days ago
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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

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

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