Manager, Facilities
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
- Primarily accountable for ensuring the technicalsuccess of the maintenance operations and the performance management of aworld-class maintenance organizational unit associated with thecommercial manufacture of all GMP products.
- Manage activities of designated functional unit inmaintenance shift or unit supervisors/leads who direct daily activities.
- Identify the technical, procedural andequipment issues that may compromise production and compliance, working closelywith cross-functional groups to identify and implement solutions.
- Manage and resolve technical andcompliance issues with Quality, Manufacturing, Manufacturing Sciences andTechnology, Reliability Engineering, Engineering, & EH&S.
- Develop weekly and monthly goals andschedules and set priorities for supervisors/leads. Evaluatesupervisors’/lead’s performance; ensure supervisors’/lead’s fair and timelyevaluation of the performance of their staff.
- Responsible for identifying andimplementing improvements in staff development in areas such as cGMP training,technical skills, safety, performance management.
- Implement and follow through oncorrective and preventative actions for variances.
- Represent the department in reviewingand approving all maintenance related documentation requiring approval such asprocess validation protocols and final reports, planned and unplanned variancereports, documentation change requests, engineering and facility changerequests, and validation protocols.
- Ensure that all operations areperformed with 100% compliance to documentation cGMP standards.
- May prepare department budgets andstrategic staffing plans.
- Assist Associate Director with settingbusiness goals and cross-functional deliverables.
- All employees with jobs that requireaccess to the Warehouse must be able to pass the Transportation SecurityAdministration (TSA) Security Threat Assessment (STA).
- Promotes a safety culture that supportcontinuous improvement in the EHS management system through activecommunication and functional area participation in site safety teams ensuringthe safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
- Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
- Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.
- Exercisesindependent judgment in developing methods, techniques and evaluation criteriafor obtaining results.
Who You Are
- Bachelor’s degree and/or FacilitiesManagement Certificate.
- Minimum of 8 years of biopharmaceuticalmaintenance experience and 3 years of supervisory demonstrated leadership.
- Possess thorough knowledge and understandingof cGMPs and familiarity with FDA guidelines
- Experiencewith start-up and validation of biopharmaceutical maintenance facilities.
- Familiar with FDA and Europeanguidelines.
- Knowledge and understanding of Qualitysystems.
- Must have expert knowledge of cGMPstandards, a proven track record of leading cGMP compliant operations throughsuccessful FDA inspections.
- Ability to lead and communicate and beable to work with other people in the organization to accomplish commondepartmental and corporate goals.
- Must be organized and flexible, capableof working on multiple tasks with changing priorities.
- Ability to supervisemaintenance/calibration staff and coordinate department activities.
- Ability to interact with internal andexternal customers including vendors and other IDEC departments and individualsto provide information, documentation or answer questions.
- Ability to mentor and coachsubordinates and develop career plans for employees.
- Ability to read and interpretengineering (mechanical/electrical/P&ID) drawings and specifications.
- Must have demonstrated the ability todrive quality and productivity improvements, have a credible, highly regardedreputation in the biopharmaceutical industry, and strong management andleadership capabilities.
- Experience in bulk protein productionand Project Management is preferred.
- Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
- Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.
- Exercises independent judgment indeveloping methods, techniques and evaluation criteria for obtaining results.
- Demonstrate organizational, timemanagement, delegation and leadership skills to achieve successful results.
- Demonstrate excellent verbal andwritten communication and comprehension skills.
- Exhibit creativity in adapting tosituations, develops contingency plans, and makes decisions.
- Proficiency with the followingsoftware: Microsoft Word, Excel, and Project.
- Ability to work in a fast paced,dynamic work environment.
- Standard office environment.
- Required to attend meetings, tour, andwork in manufacturing clean room environment.
- Environment requires that gowning inthe form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean roomenvironment.
- May work with hazardous materials andchemicals.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
