Currently, we are seeking an expert in process implementation and coordination. This is an exceptional opportunity for professionals to join a leading multinational company specializing in the production of biopharmaceuticals.
* The successful candidate will be responsible for collaborating with various stakeholders to execute the transfer requirements of late-stage clinical and PPQ programs.
* They will attend meetings with local and international groups to coordinate and execute implementation tasks for new drug substance processes.
* This role involves managing new program introduction schedules to ensure timely execution of tasks and adherence to quality standards.
* The ideal candidate will collaborate with stakeholders to deliver GMP documents related to technology transfer, such as risk assessments, change controls, batch records, sampling plans, and bills of material.
* They will also support the development of process descriptions, process models, facility fits, and other tech-transfer-related documents for continuous and fed-batch processes.
* A key aspect of this role is employing innovative and continuous improvement mindsets to identify and implement opportunities to enable product launch.
* The selected individual must ensure the highest quality, compliance, and safety standards and embody the company's safety and environmental guidelines.
* Excellent problem-solving skills, influencing, collaboration, and teamworking abilities are essential for success in this position.
To be eligible for this role, candidates should have:
* A minimum of 3 years of work experience in the pharmaceutical or biotech industry.
* A Bachelor's degree in Engineering, Biotechnology, Chemistry, or a related field.
* Technical knowledge of biologics drug substance upstream and downstream operations or process development.
* An understanding of the principles and activities of New Product Introduction NPI/Tech Transfer.
* Familiarity with automation systems in manufacturing processes, such as DeltaV, MES, eVal, and business tools like Power Project and Power BI.
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
Interested individuals can contact us for further information.