Technical Development Staff Scientist - Analytical CM&C Cell Therapy

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

Creating a world where we all have more time with the people we love. That’s what makes us Genentech.

The Opportunity

Genentech is looking for a creative, driven, and passionate scientist with extensive experience and accomplishments in leading CM&C analytical development to support late stage cell therapy development and commercialization.

The successful candidate will lead a matrix team to develop an end-to-end control system for late stage cell therapy development and commercialization.

The individual will play a vital role in advancing cell therapy development / commercialization at Genentech. The individual will serve 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.

In this role, the selected individual is responsible for devising overall control and comparability strategies to support late stage development / commercialization by working closely with others on the TDT.

Specifically, the ASTL is 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).

The individual will also interact and collaborate with partners in research (gRED), the PTD network, manufacturing, and external collaborators.

Responsibilities :

• Designing and establishing an end-to-end control system to support late stage and commercial cell therapy development including comparability strategy in close partnership with other stakeholders.
• Providing technical leadership for cell therapy analytical method development, optimization, qualification, transfer in a phase appropriate manner.
• Collaborating with research (gRed) colleagues to develop novel analytical methods in support of cell therapy development throughout the CM&C development cycle as-needed.
• Authoring IND / BLA sections or providing oversight for such authoring activities.
• Lead and support analytical method validation and transfers to clinical and / or commercial manufacturing site(s).

Who you are

Required :

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 :

• 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.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $171,600 to $318,600.

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.

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