Engineer/Sr. Engineer, Upstream Process Development

Engineer/Sr. Engineer, Upstream Process Development

Dragonfly Therapeutics seeks an upstream process development engineer who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to help deliver novel immunotherapy programs. The successful candidate will excel in a highly collaborative work environment with a multi-disciplinary and diverse team focusing on multiple programs in parallel. Candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects.  The successful candidate will contribute and drive our upstream cell culture process development, while interacting regularly with other CMC functions. 

Responsibilities:

• Lead development of robust and scalable upstream processes for biologics in different stages of clinical development, including design, execution, analysis, and documentation of all stages of cell-culture process development
• Support external manufacturing with technology transfer for implementation of new processes and provide person-in-plan support as required
• Support process change controls, deviations, impact assessments, and perform batch record review
• Improve upstream processes through research and innovation, while assessing technologies and industry best practices
• Review, collect and trend data from manufacturing batches to help identify trends, assess performance, build process understanding, and enable improvement activities
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity
• Maintain good communication and collaborate with cross-functional colleagues and external partners for successful execution/completion of projects
• Author and contribute to IND/IMPD/BLA submission

Qualifications:

• BS/MS with 10+ years, or PhD with 2+ years of industry experience and background in Chemical/Biochemical engineering, or a related field
• Strong fundamental knowledge and subject matter expertise in cell-culture process development, fed-batch cell culture, bioreactors across scales, as well as recent advances, and challenges in the field
• Experience and aptitude to lead, work and collaborate in internal and external cross-functional, matrixed teams
• Working knowledge of cGMP and quality systems
• Action-oriented mindset, ability to take initiative, innovate, iterate and problem solve
• Experience with cell culture and predictive modeling (omics, metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence a plus
• Ability and willingness for approximately 10% domestic travel consistent with project needs