Bioprocess Engineer / Senior Technology Associate
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Feb 16 2021
- 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.
- 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.
- 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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