Head Purification, Microbiology, Virology

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, a member of the Roche Group.

The PMV function is a key component of Genentech and Roche's Pharma Technical Development organization. The PMV organization provides innovative technologies and strategic support for development and commercialization of Genentech and Roche's biologic portfolio, including standard monoclonal antibodies as well as complex immunoglobulin constructs, fusion proteins, and modified proteins such as antibody drug conjugates. The strategy is directed towards 1) ensuring rapid and agile delivery of new molecules to the clinic, 2) development/validation of robust, environmentally sustainable commercial processes, 3) smooth transfer for processes to internal and external sites, and 4) development and deployment of new technologies that will enable implementation of next generation processes and modernization of our commercial production network.

The Head of PMV oversees an organization of over 100 team members including scientists, engineers and associates responsible for QC microbiology supporting all South San Francisco GMP production operations, adventitious agent testing, process virology R&D and validation, purification processes development and transfer to manufacturing operations from non-clinical studies to the registration stage of biologics. PMV works closely with a variety of Genentech and Roche groups, including Research and Product Development, all global pharma technical development functions, Cell and Gene Therapy, Roche's global manufacturing network, and external contract manufacturers. Of key importance is the accountability of the Head of PMV to partner closely with counterparts in Roche's European Research (pRED) and Technical Development organizations to drive global alignment on process development and technology strategies. The Head of PMV is also responsible for the appropriateness and accuracy of purification Drug Substance technical aspects in regulatory submissions; ensuring seamless approvals of clinical and marketing application submissions.

As a member of the Pharma Technical Development US Biologics leadership team, work collaboratively and strategically to establish priorities and direction for the organization to meet its business needs, bringing innovation and efficiency to achieve the company's long-range goals. Contribute to the development of department business initiatives and facilitate their implementation. The PMV Head collaborates with other technical functional leaders to represent Genentech's production technologies to the external community, and ensures that Genentech retains its industry-leading reputation as a leader in biotechnology process development. The Head is accountable for developing, aligning and effectively implementing long-term strategies in the overall CMC in accordance with annual priorities, business targets and overall budget. The planning horizon of this role and its staff can extend 10 years or more. Annual budget is approximately $30 million.

Job Responsibilities:

* Oversight of purification development, QC microbiology, and Process Virology sub-functions

Provide strategic and technical leadership for purification process development for Genentech portfolio projects throughout their lifecycle, ensuring timely delivery of clinical deliverables and robust commercial manufacturing processes

* Ensure developed processes are robust, incorporate sustainability elements, and are enable seamless transfer to clinical and commercial sites
* Accountable for oversight of projects by PMV Evaluation and Review and responsible to represent PMV in Senior level decision making forums
* Create a strategic direction for Purification process technology development and data management, meeting the future needs of both Technical Development and clinical and commercial customers
* Maintain tight connections and alignment of QC microbiology and Adventitious Agents Testing group with broader Roche QC network
* Ensure Genentech continues to attract, retain, and develop industry-leading technical talent at all levels
* Lead or represent Technical Development on multidisciplinary strategic initiatives along with colleagues in Quality, Regulatory and manufacturing
* Ensure effectiveness of functional area initiatives (e.g., talent development, safety programs, LEAN productivity programs, Digital Transformation)
* Develop and oversee functional area budget
* Approve key internal documents and review regulatory submissions for technical accuracy and strategic soundness
* Act as a subject matter expert within and outside of the company
* Cultivate an organizational culture of technical excellence that is high performing, agile, lean, innovative, self-motivated and encourages smart risk taking. Foster a culture where new perspectives and ways of working are explored and integrated into its operations, where meaningful and challenging assignments are available to staff, and where the decision making principles (fit-for-purpose, at the right level, clarity of process) are well established.

Requirements:

* B.S., M.S., or Ph.D. in Biology, Biochemistry, Chemical Engineering, or related discipline
* 15+ years of technical experience including at least 5 years of senior managerial experience with a group of significant scope
* A recognized leader in the BioPharma industry as evidenced by peer-reviewed publications, contributions to conferences, and white papers.
* Excellent verbal and written communicator
* Demonstrated commitment to team and organization development including inspiring an environment of continuous improvement and innovation

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 $221,000 to $410,400. 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.