ProClinical is currently seeking a Biological Researcher for its client located in West Chester, PA. Successful candidate will be responsible for developing and executing robust, efficient, scalable strategies for improving downstream process performance.
- Staging appropriate downstream process development of biologics pipeline.
- Evaluating new purification technologies to improve the efficiency of biologics manufacturing process and reduce cost of goods.
- Designing fit-for-purpose purification experiments according to the stage of development, executing the runs in process development lab, analyzing performance data and writing technical reports and preparing presentation for management update.
- Critically analyzing complex data, interpreting and integrating experimental results with project objectives and writing technical reports in timely manners.
- Assisting in troubleshooting processed, equipment issues, and deviations.
- Interacting cross-functionally with internal and external functions to support successful process development.
- Leading the execution of virus clearance study at 3rd party labs.
- Supporting cGMP clinical manufacturing campaigns in Biologics Manufacturing Facility as needed.
- Expanding the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform development, or using a literature precedent.
Skills and Requirements:
- MS in biochemical, biomedical, biological engineering or biotechnology with 6+ months of downstream biologics process development experience.
- In depth understanding and hands on experience in downstream unit operations like process chromatography in bind and elute as well as flowthrough mode, virus reduction filtration, ultrafiltration/diafiltration, etc.
- Experience using AKTA chromatography systems and UNICORN software.
- Experience in using normal flow and tangential flow filtration skids.
- Good understanding of process development and cGMP operation.
- Knowledge of protein characterization methods and analytical techniques.
- Excellent verbal and written communication skills required.
- Highly motivated individual with ability to work collaboratively in a team environment.
- Experience in downstream process development for early and/or late phase process preferred.
- Experience of cGMP production is preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £37000.00 per annum
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