Process Technology Senior Scientist
5 days ago
We are seeking a highly skilled Process Technology Senior Scientist to join our team at Alphanumeric Systems Inc. in Upper Merion, King of Prussia, PA. As a key member of our Process Technology department, you will play a critical role in the development and implementation of bioprocessing technologies.
Key Responsibilities- Process Technology Transfer: Participate in the transfer of process technology from Bioprocess development groups to GMP Operations, including internal and external groups. Conduct facility fit assessments, digital data and analytics (DDA) activities, and process introduction activities for bioprocessing unit operations.
- Technical Operations: Monitor the technical operations of the process through communication with Manufacturing Scientists.
- Matrix Team Representation: Represent the Process Technology department at multi-disciplinary matrix teams and present results/conclusions at these meetings.
- Troubleshooting and Campaign Support: Support troubleshooting production problems and the technical success of multi-million dollar biopharmaceutical production campaigns.
- Regulatory Compliance: Ensure that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings. Author campaign summary reports.
- Documentation and Training: Author, review, and edit batch documentation for cGMP processes. Provide training and guidance to Manufacturing Scientists and less experienced personnel.
- Education: B.S. or higher degree in chemical engineering, biochemical sciences, or related engineering/scientific disciplines.
- Experience: 3+ years of experience in upstream cell culture bioprocessing, with a preferred background in chemical, biological, and/or manufacturing sciences. Experience in biopharmaceutical process development, technology transfer, scale-up, and cGMP batch execution/troubleshooting is beneficial.
- Skills: Knowledge of downstream bioprocessing is a plus. Familiarity with data analytics/data visualization tools. Experience in project management and delivery, including ability to prioritize and forward plan courses of action. Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization.
Alphanumeric Systems Inc. is a dynamic company born of a diverse mindset and held to a distinctly high standard. We lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.
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