Key Responsibilities
* Partner with stakeholders to execute the transfer of late-stage clinical and/or PPQ programs.
* Attend meetings to coordinate implementation tasks for new drug substance processes.
* Manage program introductions to ensure timely execution and right-first-time delivery.
* Collaborate to deliver GMP documents related to technology transfer, such as risk assessments and change controls.
* Support development of process descriptions and other tech transfer-related documents.
* Apply an innovative mindset to identify opportunities for product launch improvement.
* Maintain high standards of quality, compliance, and safety while following safety guidelines.
* Develop problem-solving skills and ability to learn from experience.
* Cultivate collaboration and teamworking abilities in global teams.
Requirements
* Minimum 3 years' work experience in pharmaceutical or biotech industry.
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
* Technical knowledge of biologics drug substance operations or process development.
* Understanding of New Product Introduction (NPI) principles.
* Familiarity with automation systems like DeltaV and business tools like Power Project.
* Experience in GMP-regulated biological manufacturing environments.