Please note this is a Night Shift position 6:00pam to 6:30am Sunday through Tuesday (every other Sat)
Main Purpose of the Position:
Under the direction of the Filling Production Manager, the Aseptic Operations Supervisor will be
accountable for Aseptic Production Operations of liquid or lyophilized products, including
capping, tray-off and Automated Inspection.
Ensure work environment meets Genentech and industry standards. Create and maintain a safety culture that delivers injury and incident free operations. Drive achievement of departmental safety performance targets and manage operations so that all departmental, functional and site objectives are met. Reinforce safety practices/behaviors throughout the shift. Provide oversight and support to ensure safety improvement initiatives are consistently identify and implemented. Ensuring that all shift personnel have applicable safety training requirements assigned and completed.
Ensure the facility is always regulatory inspection-ready. Participate in the development of quality goals and oversee operations to ensure targets and objectives are achieved. Review trend data to ensure quality compliance and correct negative trends as required. Reinforce quality practices throughout the department. Provide oversight and support to ensure adequate quality improvement initiatives are appropriately identified and implemented in a timely manner.
Maximize production output and labor efficiency while meeting required safety and quality levels. Manage operations to ensure that production, productivity, and financial targets and objectives are met. Ensure business processes are followed and improved to deliver production performance at Class A levels. Maximize equipment utilization and Overall Equipment Effectiveness (OEE).
Apply operational excellence tools to define standard work, reduce process variability and steadily deliver measurable efficiency gains. Ensure that Continuous Process Improvement teams are supported, trained and facilitated.
Manage the execution of the production schedule and shop order sequencing to optimize use of available capacity. Maintain data and transactional sources required to support capacity models to understand real time capacity utilization and capability.
Comply with all company policies and procedures related to personnel management. Manage and mentor the performance planning process for all direct reports to ensure their success Coach and develop leads, specialists and technicians via effective development planning. Coordinate shift level hiring and staffing plans.
Complete all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc.). Ensure lessons learned or best practices are shared across the department. Leverage knowledge to maximize organizational effectiveness.
Identify and 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.
Actively manage shift labor, overtime and spending to within the approved budget on an ongoing basis.
Review and approve manufacturing documentation including batch records and SOPs. Review and support closure of discrepancy records
Participate in strategic planning, objective self-analysis for compliance, safety and quality risks, and analysis of operational strengths, weaknesses, opportunities and threats.
Qualifications / Requirements:
Bachelor’s degree in a science or engineering discipline or equivalent.
Possess a minimum of 5 years of progressively responsible experience in pharmaceutical manufacturing and specific experience in parenteral manufacturing.
Demonstrated ability to manage people and projects. Ability to work with internal teams, partners, suppliers and customers.
Current understanding of FDA and EMA guidelines, cGMP’s for Manufacturing Parenteral Drug Products, including validation requirements.
Operational Excellence and Industrial Engineering skills.
Excellent written/spoken communication and interpersonal skills.
Proficiency with validated change management, discrepancy management, inventory management, and production control systems.
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.