Head of ADQC - Biological Technologies

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, a member of the Roche Group.

The Opportunity

Genentech is inviting applications for the Head of Biological Technologies (BT) function, a Senior Director-level role within the Analytical Development & QC (ADQC) department in the Pharma Technical Development (PTD) organization.

The BT group is responsible for the development and validation of all in vitro biological methods, which are used in the QC control systems of Genentech clinical and commercial products, and the host cell protein (HCP) strategies.

The group also supports 1) GMP / GLP lot release / stability testing for clinical products, 2) potency and large molecule impurity testing for process development, product characterization, comparability, CQA assessment and versions v1.

x improvements, and 3) training, transfer and troubleshooting of biological methods to Genentech commercial sites and collaborators / contract manufacturers.

Key Stakeholders and Interfaces include Commercial Quality, Genentech Research, PTD-Europe, Regulatory, other technical development functions and Technical Development Teams.

Responsibilities :

Lead and manage a team of 60 Scientists, Managers, and Technical Associates while demonstrating Roche Leadership capabilities and principles

Set strategic directions for the BT organization, contribute to the ADQC business strategy, and sponsor ADQC initiatives / projects.

Foster staff development and growth, provide feedback, and offer skill development opportunities and recruit top scientific talent.

Accountable for and provides oversight for the training, development, validation, technology transfer, and testing of potency and HCP methods for clinical and to-be-marketed products, while leading a team that develops biological methods for the same products and drives scientific innovation in potency and HCP testing.

Support QC sites during potency method investigations and provide technical input in investigations and testing strategies.

Interpret and improve Quality policies, procedures, and processes.

Provide input to budget and resource allocation, monitor expenditures.

Develop strategies for Biological Characterization submission and CQA assessments.

Collaborate on policies & procedures, interact with and influence cross-functional organizations, external partners, and Health Authorities.

Who You Are

Required :

PhD, B.S. or B.A. degree and twelve years relevant experience in the biopharmaceutical industry developing Immunological or cell based assays that are representative of the biological mechanism of action for biopharmaceutical products.

The candidate will be influential and able to work collaboratively across a global organization.

The successful candidate will be a proven people leader, who can develop and retain scientific talent.

Preferred :

PhD or Master’s degree in Life Sciences

Large team leadership experience in a complex cross-functional environment

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 $202,100 to $375,300.

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.

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.