Senior Supervisor, Facilities

South San Francisco, California

Job ID: 00425889

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

Manage Genentech’s South San Francisco mechanics’ group in Drug Product Process Equipment Maintenance Execution organization. Provide leadership to meet manufacturing and company goals in staff development, safety, product quality, production efficiency, and leadership. Ensure operation of facilities is in compliance with cGMP’s, OSHA, environmental, labor and other governmental laws and regulations. Follow appropriate documentation and quality systems. Ensure department goals and priorities are appropriately established in alignment with Manufacturing and company goals. Allocate and prioritize resources (people, materials, equipment, facilities, and processes) to meet departmental and company goals and objectives. Help develop and implement strategies to meet current and future production needs. Participate in regulator inspections. Interpret and support the defense of SSF Manufacturing policies and activities to regulator agencies. Help manage budgets. Provide forecasts to personnel of strategic plans of organization. Ensure timely personnel career development, coaching, and performance feedback. Review and approve manufacturing documents and regulatory submissions. Ensure staff is informed of production issues, project status and plans. Facilitate leadership on process improvements, investigations; root causes analysis, and project teams. Establish and maintain solid working relationships with other Genentech departments. Provide representation of SFFP Inspection in matters affecting the department. Participate and promote continuing education for self and department. Ensure consistent and sustainable departmental operation. Develop and/or improve departmental capabilities in response to corporate needs, industry practices, and regulatory agency expectations. Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.


Job Responsibilities

Essential

• Represent Inspection Operations in matters affecting the department with other functions within the Genentech organization.
• Plan, structure and organize a productive, capable and skillful maintenance team
• Provide personnel career development, coaching, and feedback including quarterly performance management discussions with each direct report.
• Administer staff-level compensations issues.
• Track departmental measures and write monthly summary reports.
• Set goals, objectives, and priorities. These include meeting customer needs on time and in full, as directed by planning and scheduling.
• Approve purchase requests.
• Review and approve SOPs.
• Review and support closure of manufacturing variances (DMS) and incident reports.
• Enhance safety, efficiency, and quality attributes of manufacturing operations.
• Lead weekly staff meetings with direct reports.
• Participate in SSFP DP Leadership Team staff meetings and Governance meetings. 
• Work with operations supervisors to meet current production requirements and address manufacturing priorities.
• Work with Quality & Compliance to ensure inspection readiness at all times
• Develop viable contingency plans that ensure that unforeseen problems do not prevent successful completion of the production schedule or department projects.
• Work with Operations, Support Engineering and Quality to define readiness criteria, and document set up parameters as needed to reduce variability associated with set up.  Devise and develop gauges, indicators and other set up accuracy verification tools as the opportunity arises to minimize adjustments needed during fill.  Identify and take effective actions to reduce complexity and streamline set up such that is steadily becomes less error prone and time consuming
• Work with production planning and other groups to assess the long term requirements for the department and implement plans to help meet future manufacturing demands.

Who You Are

Job Requirements

Education and Experience

• Detailed and specific knowledge of aseptic processing equipment operating principles set up requirements and preventive maintenance requirements.
• Specific and applicable understanding of current Good Manufacturing Practices especially as related to supervision of operations, documentation, batch release and inspection readiness of facilities and processing equipment.
• BS/BA degree (minimum) in Life Science, Physical Science, Engineering, or at least  three years of GMP production experience, greater than five years of maintenance experience

Knowledge, Skills, and Abilities

• Strong interpersonal, communication and problem solving skills are required as well as successful demonstration of leadership, teamwork and technical expertise.
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMP).
• Requires familiarity with manufacturing processes and operations, industrial automation (e.g., distributed control and PLC-based systems), equipment/facilities validation.
• Working knowledge of SAP, EXCEL and DMS systems.

Work Environment/Physical Demands/Safety Considerations

Be able to lift 50 lbs.
Be able to work flexible hours by supporting a 24/7 operations
Be able to work extensive hours while standing sitting or bending as necessary
Working with/around various chemicals (i.e. acids and bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA).
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.

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Job Facts

Job Function

Technical Functions and Maintenance

Location

United States - California
South San Francisco

Company/Division

Pharmaceuticals

Schedule

Full-time

Job type

Regular Employee

Job Level

Manager with Direct Reports