Technical Development Staff Scientist

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The Opportunity

Genentech is looking for a creative, driven, and passionate scientist with extensive experience and proven accomplishments in leading CM&C analytical development to support late stage cell therapy development and commercialization. You  will lead a matrix team to develop an end-to-end control system for late stage cell therapy development and commercialization.  You will need strong and effective leadership skills as well as in-depth experience and knowledge in CM&C strategic planning. You will also play a vital role in advancing cell therapy development/commercialization at Genentech.  

As the Analytical Sub-team Lead (ASTL) on the Technical Development Team (TDT) in the Pharma Technical Cell & Gene Therapy (PTC) organization based in South San Francisco,  you will devise overall control and comparability strategies to support late stage development/commercialization by working closely with other collaborators on the TDT.  Specifically, you are accountable for ensuring that appropriate and suitable analytical methods are developed, qualified, transferred and/or implemented to support late stage development and commercial licensure. Other responsibilities include leading and coordinating a team of technical development/regulatory scientists to support process development/optimization (CPP determination) and product understanding (CQA identification).  As an ASTL, you will also interact and collaborate with partners in research (gRed), pharma technical development (PTD) network, manufacturing, and external collaborators.

What You’ll Do

• You will 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. 

• You will provide technical leadership for cell therapy analytical method development, optimization, qualification, transfer in a phase appropriate manner

• You will collaborate with research (gRed) colleagues to develop novel analytical methods in support of cell therapy development throughout the CM&C development cycle if necessary

• You will author  relevant IND/BLA sections or providing oversight for such authoring activities

• You will lead and support analytical method validation and transfers to clinical and/or commercial manufacturing site(s).

Who You Are

• You have a Ph.D., Masters, or Bachelors 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

• You have strong technical and people leadership skills and capable of working within a highly dynamic, cross-functional team to achieve organization goals

• You have a strong background and understanding in standard and advanced analytical techniques for cell therapy development (Flow cytometry, NGS, ELISA, cell-based assays, etc.) 

• You have in-depth knowledge and experience in analytical development, method transfer, overall control strategy for early as well as late stage clinical development and commercialization 

• You have experience in the field of cell and gene therapy products

• You have an agile and flexible way of working, acute trouble-shooting and problem-solving skills, and willingness to take risks and ability to make difficult decisions under ambiguous and challenging situations.  

• You are able to independently manage complex situations as well as to coordinate multiple tasks and manage priorities

• You have effective verbal and written communication skills including the ability to present scientific results clearly and concisely

Relocation funding is available for this role

The expected salary range for this position based on the primary location of South San Francisco, CA is $180,700 - $$335,500.. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.