What are the responsibilities and job description for the Upstream Process Development Group Lead position at Workforce Genetics?
Job Description
Job Description
FULL-TIME POSITION : Upstream Process Development Group Lead (Up to Associate Director)
Job Summary :
Our client is seeking highly motivated applicants with an entrepreneurial spirit for an open position in our biosimilar and biodefense development programs. The selected candidate will support early- and late-stage process development of mammalian cell culture processes.
Responsibilities include but are not limited to :
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 research and innovation, while assessing technologies and industry best practices.
Participate in or lead internal manufacturing activities : technical transfer and manufacturing support.
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 relations.
Required Experience and Skills :
Strong fundamental knowledge and subject matter expertise in cell-culture process development 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, and documentation 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 their use in process development, optimization, and characterization.
Strong troubleshooting skills, including overcoming difficult process challenges and manufacturing implementation.
Preferred :
Experience with NS0 cell lines, Catalents GPEx technology with GS knock-out CHO cell line, and Lonzas CHO GS Exceed Gene Expression system.
Track record of accomplishments in upstream bioprocessing.
Minimum Qualifications :
Bachelor's 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.
Familiarity with Microsoft Office (Word, Excel, Powerpoint, etc.)
An All-In attitude due to the 24-7 nature of cell culture work (weekend work, late-night adjustments to bioreactor conditions, etc.)
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