Upstream Process Development Scientist—Frederick, MD
Responsibilities :
- Participate in or lead development of robust and scalable upstream mammalian cell culture
processes for biologics in different stages of clinical development.
Advance upstream processes by improving efficiency and cost effectiveness through researchand innovation, while assessing technologies and industry best practices.
Participate in or lead internal manufacturing activities : technical transfer and manufacturingsupport.
Participate in or lead external development and manufacturing activities at external partners :development work, technical transfer, and manufacturing support.
Participate in or lead process validation activities for successful commercialization.Contribute to strategic initiatives; partner with senior leaders to set overall project strategy,and guide teams towards its execution.
Mentor and actively share expertise and build strong collaborative relation.Required Experience and Skills :
Strong fundamental knowledge and subject matter expertise in cell-culture processdevelopment for biologics, perfusion and fed-batch cell culture, bioreactors across scales, as
well as recent advances, and challenges in the field.
Expertise in independently conducting and directing the design, execution, analysis, anddocumentation of all stages of cell-culture process development.
Operation of Repligen ATF systems.Operation of XDR and BioBlu bioreactors.Operation of AMBR high-throughput bioreactor systems.Operation of NovaFlex, ViCell Blu and other analytical instruments.Familiar with DoE principles and its use in process development, optimization andcharacterization.
Strong troubleshooting skills, including overcoming difficult process challenges andmanufacturing implementation.
Preferred Experience :
Experience with NS0 cell lines, Catalent’s GPEx® technology with GS knock-out CHO cellline and Lonza’s CHO GS Exceed® Gene Expression system.
Track record of accomplishments in upstream bioprocessing.Minimum Qualifications :
Bachelor degree in biochemical engineering or life sciences.Hands-on experience in mammalian cell culture process development.Strong attention to detail.Must be organized and self-motivated.Excellent time management and proven ability to complete projects on time.Excellent level of initiative, creativity, and quest for knowledge.Must have excellent communication and writing skills
