BS/BA in either biological or chemical science or engineering or equivalent technical discipline.
• A minimum of 3 years post-graduate experience in the Biopharmaceutical/ pharmaceutical industry or equivalent.
• Knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
• Preferably has at least 1 year of experience in the development of biopharmaceutical drug substance manufacturing processes.
M.S. in either biological or chemical science or engineering or equivalent technical discipline.
• Knowledge in biopharmaceutical technologies such as large scale cell culture/microbial technology, biopseparations technologies, or pharmaceutical manufacturing of proteins. Basic understanding of analytical technologies related to the above.
• Strong interpersonal and leadership skills.
• Strong verbal and written communication skills.
• Strong Analytical and critical thinking skills.
• Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
• Able to prioritise, and decide appropriate courses of actions. Effective at implementing decisions.
• Committed team player prepared to work in and embrace a team-based culture.
• Support managing certain elements (such as upstream or downstream etc.) of the transfer of primary(drug substance) biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organisations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites.
• Assist in supporting delivery of new biopharmaceutical applications and technologies as well as on delivering improvements to the existing supply chains supported by GMS Biopharm and technology transfers between GMS Biopharm & R&D.
• Determine adequacy of plant to accept new technologies and appropriate actions to implement start of new process operations.
• Responsible for development and preparation of technology transfer/process validation protocols and "hands-on" startup of production processes with operators.
• Responsible for preparation and presentation of technology transfer/process validation reports or documentation.
• Define training program for operators as part of technology transfer and when required train process operators.
• Identify potential process problems, provide technical advice to Production and/or Quality Department to resolve process problems.
• Advise management as to possible opportunities for process improvements.
• Collect and track process trend data and monitor process trends. Determine causes of process variances and recommend corrective actions.
• Stay current with developments in the fields of biotechnology and bioprocessing. Responsible for learning and understanding process technologies under development within R&D.
• Demonstrate the use of OE tools and philosophies.
• As necessary will be required to carry out laboratory based biopharmaceutical process development/investigational activities.
• Independently design basic lab experiments and interpret data/results with minimal supervision.
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