Genentech - A Member of the Roche Group

/ Hiring

Director, South San Francisco Production Technology

South San Francisco, California
Job ID: 00414252

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Reportingto the Vice President – SSF  Production, the Director of Technology willbe responsible for manufacturing science, validation, automation, recipe anddocument development and engineering functions in direct support of production.

*Provide support to operations departments in make, assess, release activities;plan and execute process related capital projects within the plant incollaboration with Corporate Engineering; work closely with GlobalManufacturing Sciences and Technology (MSAT), Process R&D, RegulatoryAffairs and Quality, representing the plant on technology transfers, regulatoryagency inspections and other issues and projects; foster innovation intechnologies, processes and systems as part of continuous improvement and cGMPefforts.
* Ensure goals, priorities, budgets and strategic plan are appropriatelyestablished and aligned.
* Ensure proper resources are available (people, materials, equipment,facilities, processes) to meet current and future goals.
* Ensure an uninterrupted supply of product in the near- and long-term.
* Ensure systems are in place to successfully complete regulatory inspections.
* Plan & manage to continuously improve safety, quality, reliability andefficiency.
* Actively promote and lead Continuous Process Improvement (CPI), Root CauseAnalysis (RCA), and risk assessment tools such as FMEA.
* Ensure qualified staff are hired, trained, developed, and recognized.
* Develop, review and approve GMP documentation and regulatory submissions.
* Work in partnership with other Genentech staff to develop and championpolicies, best practices, decisions and strategic plans.
* The incumbent will be responsible for directing, managing, and orchestratingTechnology functions within the South San Francisco Drug Substance and DrugProduct manufacturing facilities utilizing CHO and Bacterial production systems,and liquid and lyo fill lines to make commercial and clinical product.  

Who You Are

* 10-15years of senior leadership /management experience
* Bachelor of Science in engineering or science, with advanced degree preferredin science, engineering and/or business (MBA).
* Demonstrated success in human biopharma or pharmaceutical industry,preferable in process science or manufacturing with significant cGMP experience
* Excellent communication skills, exceptional people management and strongleadership skills
* Demonstrated significant individual drive and a real passion to contribute;she/he approaches work with incredible enthusiasm and intellectual curiosityspecific to solving far-reaching technical, scientific and business challengesand is able to position her/his teams in a similar fashion.
* Candidate is not only comfortable with ambiguity in a fast-pacedenvironment, but will see this as an opportunity to drive improvements

* SSF Production is a24/7 operation, and the Technology function supports operations around theclock, every day of the year.  As aresult, the leader of Technology will need to be available to respond to andescalate significant issues outside of normal business hours.  In addition, during peak periods of work,such as FDA inspections, the leader of Technology will need to work beyondnormal work hours.  

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.

Job Facts

Job Function
Management Production
Location
United States - California
South San Francisco
Company/Division
Pharmaceuticals
Schedule
Full-time
Job type
Regular Employee
Job Level
Executive (Director/VP/SVP)