
Global Process Transfer Specialist
3 days ago
Key roles in this position include facilitating the transfer of clinical and commercial product processes, collaborating with stakeholders to ensure smooth execution of transfer requirements for these programs.
- Coordinate implementation tasks for new drug substance processes by working with local and international teams.
- Manage program introduction schedules to guarantee timely completion of tasks and adhere to quality standards.
- Develop and deliver GMP documents related to technology transfer, including risk assessments, change controls, batch records, sampling plans and bills of material.
- Support the creation of process descriptions, facility layouts, and other technical transfer-related documents.
- Evaluate opportunities for product launches and promote a culture of continuous improvement.
- Maintain the highest standards of quality, compliance and safety, adhering to company guidelines on safety and environmental responsibility.
- Apply problem-solving skills and collaborate effectively with global teams to achieve common goals.
Qualified candidates will have a minimum of 3 years' experience in the pharmaceutical or biotech industry, a Bachelor's degree in Engineering, Biotechnology, Chemistry or a related field, and knowledge of biologics drug substance upstream and downstream operations. Additionally, they should possess an understanding of NPI/tech transfer principles and activities, as well as familiarity with automation systems and business tools.
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