The Biological Technologies (BT) group is part of the Analytical Development & Quality Control Department within the Pharma Technical Development (PTD) organization. The BT group is responsible for the development and validation of all in vitro biological methods that are used in the QC control systems of Genentech clinical and commercial products. The group also supports 1) GMP/GLP lot release/stability testing for clinical products, 2) potency 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, gRED, PTDE, PT Regulatory, other technical development functions and Technical Development Teams.
Lead a group of 68 Scientists, Managers and Technical Associates
Direct staff and operations to oversee the development, validation, transfer and testing of potency methods for clinical and to-be-marketed products from Phase I to BLA filing.
Set strategic direction for BT organization. Select, hire, and train top scientific talent to deliver pipeline molecules.
Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities
Interpret, execute, and recommend improvements to Quality policies, procedures, processes to meet quality and business objectives
Provide input to department budget and resource allocations and monitor and control expenditures against the department budget
Be accountable for behaviors described in the Roche Leadership capabilities
The successful candidate will have the skills and ability to effectively perform the following:
Oversee a multi-functional organization which supports a continuum of biological activities from early stage development to market
Lead a team responsible for development, validation and transfer of biological methods for clinical and to-be-marketed product from Phase I to BLA filing, in support of GMP/GLP lot release/stability testing and potency testing for process development, comparability, product characterization, CQA assessment and version 1.x improvements.
Lead scientific innovative effort to identify, evaluate and implement novel technologies for potency testing
Accountable for method selection/development/validation strategy and execution
Develop, execute and defend phase appropriate validation strategies, and strategies for specification setting
Develop and defend strategies for Biological Characterization submission and CQA assessments including development/selection of characterization assays, sample selection/testing, data interpretation and authoring BLA section
Accountable for potency assay training and technology transfer strategy and execution
Support QC sites during potency method related investigations/root cause analysis
Provide technical and strategic input into product quality investigations and design testing strategy to support investigation
Provide technical and quality control input during the review and approval of applicable documents
Collaborate and/or author department or network policies & procedures as needed
Interact (Communicate and Negotiate) with cross-functional organizations, external organization (CMO, Roche partners) and Health Authorities (FDA, EMA and others)
Influence Biopharmaceutical industries and Health Authorities on trends and policies in the field of potency assays by actively participating in conferences and workshop
Expected to exhibit strong teamwork and collaborative skills with strong verbal and written communication
Bachelor's, Master's or PhD degree in Life Sciences or other relevant discipline.
12+ years of relevant experience in the biopharmaceutical industry developing immunological or cell based assays that are representative of the biological mechanism of action for biopharmaceutical products.
Influential and able to work collaboratively across a global organization.
Proven people leader, who can develop and retain scientific talent.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.