Bioprocess Engineer / Senior Technology Associate

Key Responsibilities

• 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.

Basic Qualifications

• 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, ICH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
• At least 1 year of experience in the development of biopharmaceutical drug substance manufacturing processes.
• 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.

Preferred Qualifications

• 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 prioritize, and decide appropriate courses of actions.
• Effective at implementing decisions.
• Committed team player prepared to work in and embrace a team-based culture.

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