Senior Director, Head Attribute Sciences, PTC

Roche Pharma Global Technical Operations (PT) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges as the Analytical landscape is evolving very quickly.

Genentech is seeking an experienced senior leader to establish an Attribute Sciences team within the Analytical Development (AD) department at Genentech PTCC, South San Francisco. Within Analytical Development, the Attribute Sciences team provides the end-to-end attribute sciences strategy from pre-IND to commercialization and post-commercial lifecycle. The senior director will be responsible for establishing Attribute Sciences capabilities and for leading the development and execution of product knowledge strategies that support the development of Genentech's Cell and Gene therapy product portfolio.

The senior leader will partner with research, translational medicine and Quality to understand the biology and mechanism(s) of action associated with Genentech/Roche cell and gene therapy products, drive identification of new relevant biomarkers, and establish phase appropriate control system strategies including the implementation and lifecycle management of CQA. In this role, the leader will drive analytical innovation including multi-attribute testing, and rapid analytics to improve assay turn-around time, increase efficiency and reduce cost. They will drive the implementation of state-of-the-art technology and method platforms to enable enhanced product understanding that informs next generation process development, supports regulatory filings and responses to regulatory requests. The Senior Director will lead in-process characterization and the generation of data that increases the understanding of the impact that critical materials and manufacturing processes changes can have on the product quality of cell therapy products. The senior leader will collaborate with MSAT and Manufacturing teams to support out of specification (OOS) and deviations to enable root cause analyses and communication of results to health authorities. The leader will collaborate cross-functionally to implement front-end tools and back-end infrastructure that enables data digitization, establishes bioinformatic pipelines and predictive models using machine learning/artificial intelligence in order to enhance data mining capabilities that increase manufacturing process and product understanding.

Key Responsibilities & Job Requirements

• Establish the Attribute Sciences function, define and lead execution of product knowledge generation strategy and application of product understanding to enable all aspects of CMC and clinical development

• As a key leader in the technical development organization, this role has an important role in interfacing with Research, Translational Medicine and Toxicology teams, linking product understanding to mechanism of action and therapeutic effect

• Lead the Attribute Sciences team to leverage current and emerging concepts and analytical technologies to generate product understanding and for defining and establishing product quality control strategies based on product design and intended mechanism of action

• Lead and collaboratively contribute to the development, optimization, qualification and implementation of characterization assays intended to meaningfully interrogate characteristics and properties of complex modalities

• Influences the vision, definition and development of the overall analytical strategy for gene editing reagents and critical materials, non-viral and viral vectors, supporting a portfolio of cell and gene therapy programs

• Facilitate use of product/process understanding as a key input to development and justification of phase-appropriate, mechanistically relevant control strategies for release, stability, and process control

• Leads and influences the organization in providing effective and collaborative analytical support to cross-functional teams including process development, candidate development, and platform research teams and contribute as a critical scientific voice to overall candidate and product development strategy

• Communicate scientific data and information effectively through presentations, protocols, test methods and reports, and where appropriate, through external presentation/publication in scientific and technical forums

• Lead authoring and internal review of regulatory submissions and engage in dialogue with health authorities supporting regulatory review of IND/CTA/IMPD/CTN applications for first-in-human clinical studies and associated internal source documents

• Directly supervise scientific team members (will start with 3-4 direct reports with potential growth to 8 to 10+) to deliver on functional technical development objectives by providing scientific leadership and technical oversight for multiple projects while contributing to growth and professional development.

• Provide mentorship and guidance to additional team members and contribute to establishing and growing a strong, engaged culture within technical development, built on scientific competency and technical excellence, collaboration, and effective communication

Qualifications & Experience

• Prior experiences leading an Attribute Sciences team supporting allogeneic or autologous cellular therapies

• Experience establishing business processes to define CQA, establish robust control system strategies, and inform process risk-assessments i.e. FMEA,

• Experience developing appropriate analytical comparability strategies for cell and/or gene therapy programs

• Experience supporting regulatory submissions to enable FIH to commercial filing and post-approval changes

• Experience collaborating with PD, MSAT organizations to enable root cause analysis and troubleshooting as part of deviation and/or OOS investigations

• Strong grasp of cGMP principles

• Doctorate degree in Biology, Immunology or a related scientific field and 10+ years of relevant industry experience; Master's degree and 13+ years of relevant industry experience; Bachelor's degree and 15+ years of relevant industry experience

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 $205,900 to $382,500. 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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