Executive Director, Cell and Gene Therapy, Analytical Development and Testing (ADT)

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 Roche!

This Analytical Development and Testing (ADT) Executive Director is responsible for leading clinical products quality control, lot release, stability program, analytical development, method qualification, validation, transfer, and R/D testing support for all ITCT products across different Genentech and Roche PTC sites.

Major Duties and Responsibilities

• Key accountabilities: QC testing, release, stability, extended characterizations for clinical products

• Strategy Development & Execution: Work closely with Pharma Technical leaders to ensure CMC strategy is aligned with the broader PT ambitions; Work with collaborators to develop product strategy in a phase appropriate manner in alignment with TDT; Set control system strategy and ensure technical excellence of ITCT analytical control work packages across a wide range of modalities including nucleic acid, vaccines and cell therapies.

• Enterprise-wide Perspective: Provide strategic insights and ensure customer focus in project deliverables; Maintain regular updates to senior management, and governance committees, ensuring transparent decision-making.

• Organizational Leadership: Lead ADT teams in South San Francisco, Hillsboro and other groups in the network; ensure positive employee engagement, training, development and administer resources according to product development needs. Drives the development and execution to commercialize Roche Genentech's first Cell Therapy products. Oversee department budget, anticipate and resolve issues, developing contingency and risk mitigation plans.

• Innovation: Work with internal and external collaborators to ensure PTCC maintains leadership in developing ATMPs.

• Representation: Represent Pharma Technical functions to internal and external partners including but not limited to gRED, PTD, industry working groups, collaborators and health authorities

• Decision-Making: Serve as the primary decision-maker for analytical control strategy and control system in alignment with PTC governance.

• As part of the the PTC Cell Therapy Development Leadership team, contribute to improving the PTCC's scientific reviews, prioritizations and may lead department initiatives

The role demands technical depth in ATMP development, excellent communication, collaboration, strategic and critical thinking, decision-making, negotiating, and influencing skills with senior leaders in Genentech/Roche and partners. Coaching and developing employees are a critical part of the role.

Required:

• Ph.D in chemistry, pharmaceutics, biological or related field

• 20+ years of experience in the pharmaceutical industry, with prior experience as a department head

• Advanced understanding and practice of CMC development and a history of successful innovations and working knowledge of ATMP CMC development (including Cell Therapy) is a must.

• Track record of leading analytical development and QC organizations in highly dynamic environments

• Program Management: Demonstrated ability to handle complex, cross-functional programs and innovate new ideas and approaches. Ability to work proactively and think strategically. Strong negotiation and decision-making skills.

• Collaboration: Effective collaborating with team members and senior management, including PT and gRED senior leaders.

• Successful experience working with third parties such as CDMOs and CROs.

• Communication: Excellent verbal and written communication skills, with a history of influencing

• Have successfully integrated organizations from different locations, cultures and capabilities to achieve high performance and results

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of South San Francisco, CA is $235,700 to $437,700 annually. 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.