Senior Scientist

3 days ago


San Francisco, California, United States Genentech Full time
About the Role

Genentech is seeking a highly skilled and experienced Senior Scientist to lead our cell therapy development efforts. As a key member of our Technical Development Team, you will be responsible for developing and implementing analytical methods to support late-stage cell therapy development and commercialization.

Key Responsibilities
  • Design and establish an end-to-end control system to support late-stage and commercial cell therapy development, including comparability strategy in close partnership with other stakeholders.
  • Provide technical leadership for cell therapy analytical method development, optimization, qualification, and transfer in a phase-appropriate manner.
  • Collaborate with research colleagues to develop novel analytical methods in support of cell therapy development throughout the CM&C development cycle as needed.
  • Author IND/BLA sections or provide oversight for such authoring activities.
  • Lead and support analytical method validation and transfers to clinical and/or commercial manufacturing sites.
Requirements
  • Ph.D., Masters, or Bachelor degree in biology, biochemistry, analytical chemistry, chemical engineering, or a related field and 8 to 10 years (Ph.D.) or 10 to 15 years (Masters or Bachelor) of direct experience in analytical development and CM&C.
  • Experience in the field of cell and gene therapy with extensive and direct working knowledge in supporting cell therapy development from early phase to eventual product licensure.
  • Strong technical and people leadership skills and capable of working within a highly dynamic, cross-functional team to achieve organization goals.
  • Strong background and understanding in standard and advanced analytical techniques for cell therapy development (Flow cytometry, NGS, ELISA, cell-based assays, etc.).
  • In-depth knowledge and experience in analytical development, method transfer, overall control strategy for early as well as late-stage clinical development and commercialization.
  • In-depth experience and knowledge in CM&C strategic planning.
Preferred Qualifications
  • Agile and flexible way of working, acute trouble-shooting and problem-solving skills, willingness to take risks and ability to make difficult decisions under ambiguous and challenging situations.
  • Ability to independently lead complex situations as well as to coordinate multiple tasks and priorities.
  • Effective verbal and written communication skills including the ability to present scientific results clearly and concisely.
  • A strong desire to work in a collaborative, multi-disciplinary environment; demonstrated ability to effectively interact with cross-functional teams.
  • Customer-focused, product-centered, motivated, results-oriented, and detail-minded with excellent organizational skills.
  • Expectations for this position include effective leadership competence, excellent interpersonal skills, demonstrated ability to work with others, proven trouble-shooting capabilities, solution-oriented way of working, and strategic end-to-end thinking.


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