Technical Development Principal / Senior Principal Engineer or Scientist

• Lead a team of cell culture engineers / scientists in the development of scalable, robust, efficient and sustainable cell culture processes for the production of biologics (for Senior Principal level)

• Represent the function on cross-functional project teams, where they will collaborate with leads from other functions on all aspects of CMC project deliverables. The scope of supported projects includes those in both early- and late-stage clinical development.

• Train and mentor team members to enhance their skills and promote professional growth

• Stay updated on industry trends and advancements in cell culture technology

• Collaborate with representatives from research, manufacturing, quality, and regulatory functions

• Responsible for authoring sections in regulatory filings, as well as responses during Health Authority Q&A

• Serve as an ambassador for the function with the ability to influence stakeholders for new technology implementation

• Ph.D. in Chemical Engineering or related field with 4+ years of relevant experience is required (7+ years experience for Senior-Principal level)

• Advanced technical experience supporting CHO cell culture process development activities

• Extensive practical and theoretical expertise in process development and manufacturing, with deep understanding of the drug development process

• Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams

• Strong written and verbal communication skills

• You have previous experience as a team leader or cross functional leader

• Bio-Pharma industry experience

• Experience in developing and implementing models for CHO cell culture process development and optimization

• Experience in cell culture media development

• Experience in creating the strategy of the design of an experiment and how to optimize productivity of the process (increase yield)

• Experience in scale-up and tech transfer.

• Experience in working with bioreactors, pilot plants and maintaining shake flasks

• Scientific publications experience

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