Job Description
We are currently recruiting for an exciting opportunity with a leading biopharmaceutical organization. This is an excellent position for anyone looking to join a multinational company who excels in their field.
* Collaborate with stakeholders to execute the transfer requirements of late stage clinical and/or PPQ programs.
* Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
* Manage new program introduction schedules to ensure tasks are executed on schedule and right-first-time.
* Deliver GMP documents related to Tech Transfer, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
* Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
* Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines.
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Required Skills and Qualifications
* Minimum 3 years of work experience in the pharmaceutical or biotech industry.
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
* Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
* Understanding of New Product Introduction NPI/Tech Transfer principles and activities.
* Familiarity with automation systems in manufacturing processes and business tools.
* Demonstrated experience in GMP-regulated biological drug substance manufacturing environments.
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Benefits
This role offers an excellent opportunity to develop your skills and career in a dynamic and growing industry. If interested in this posting please feel free to contact us for further information.