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US-PA-Malvern: Senior Scientist, Biologics Drug

Date: 05-Mar-2015
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Senior Scientist, Biologics Drug

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The successful candidate will design development workflows and studies, collect, record, and interpret data appropriately. Data will be presented at internal and external meetings. The candidate will be capable of training other personnel on techniques and equipment. He/she will write technical memos with minimal review and keep abreast of scientific developments in relevant fields. New concepts learned in this way will be introduced into the workflow

Qualifications

MS with at least 10 years industry experience in Chemical Engineering or Pharmaceutical Sciences or related scientific discipline OR a PhD with at least 3 years industry experience in Chemical Engineering or Pharmaceutical Sciences or related scientific discipline is required

Knowledge and experience of biopharmaceutical process design is required; fill/finish operations strongly preferred Competency at trouble-shooting process issues based on scale-down/scale-up experience is strongly preferred Understanding and experience with Lifecycle approach to Process Validation is strongly preferred Experience with formulation development of biologic products is required

Experience with lyophilization process development is preferred

Strong knowledge and experience of technology transfer operations is preferred. A strong understanding and experience in the application of various GXP and QbD concepts is preferred Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, CE, SDS-PAGE, IEF, and particle methods) is preferred Familiarity with additional analytical techniques such as DSC, rheometry (including viscometry), light scattering (SLS and DLS), and interfacial tension is preferred Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices are preferred

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/