California, United States of America
At Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.
The Head of Manufacturing - CCP2 - upstream/downstream is accountable for safe, cost-effective and efficient manufacturing operations, which in full compliance with current Good Manufacturing Practices and Roche’s corporate principles, quality policies and standards. This position ensures market demands are safely met, in adequate time and quantities, and always seeking for balance between quality, competitive cost and time for production.
The focus of Vacaville is Drug Substance manufacturing. The Head of Manufacturing is a member of an extended PT LT and a member of the Vacaville Site Leadership Team.
Develop and communicate organizational strategies, which proactively promotes a positive safety and quality culture and GMP operating principles to achievement of long term goals.
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.
Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
Build a strong pipeline of talent and robust succession plans for key positions.
Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
Build a culture of continuous improvement and model lean leadership principles.
Partner with the Vacaville Leadership Team on strategic business direction and decisions.
Build and maintain strong partnerships with other site and network leaders to promote collaboration and assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationship.
Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.
Ensure production of quality products according to Health Authority requirements, Roche PQS, incl. DMS, CAPA, QRM, TCM.
Optimize production output and labor efficiency while meeting required safety and quality levels.
Continuous improvement of manufacturing procedures and related equipment in collaboration with MSAT, F&E, and Quality
Participate in the development of production, productivity, and financial goals and manage operations so that all site goals are met.
Ensure cGMP compliance and inspection readiness for all reporting departments at all times. Actively support inspection activities.
Ensure the condition of all equipment, premises, and infrastructure in the manufacturing area. Front line owners of manufacturing plants and systems. Identify, and arrange any necessary repairs, maintenance work or technical or structural reworking within the framework of the respective competences in cooperation with the Facilities and Engineering, and MSAT groups.
Operate within the validated state of processes and equipment.
Ensure that staff are appropriately trained and qualified for the activities they perform.
Support the development of the production plan and ensure conformance with production schedules.
Responsible for IPC analysis and ensuring that the planned production can run without delay.
Further develop the operating procedures and equipment in accordance with the state of pharmaceutical technology, provided that a quality or production improvement can be achieved or a GMP requirement can be met.
Represent manufacturing in defining and refining validation strategy, investigations and technical transfers.
Continuously monitor deviations and define and implement sustainable measures to reduce deviations. Promotes problem identification and a culture of proactive problem prevention.
Be a strong network partner through sharing best practices and lessons learned.
Actively develop employees, create a climate of continuous improvement, high engagement and motivation, flexibility and agility.
Build strong partnerships with the site leadership team to ensure alignment around strategic priorities and day to day priorities.
Lead and manage the Safety Health and Environment elements of the organization appropriately.
Who You Are:
You hold a Bachelor’s degree (science or engineering, preferred); Graduate or higher-level degree, preferred.
At least fifteen (15) years of manufacturing/production experience at a management level in the pharmaceutical industry
8-10 years’ people management experience
Expert knowledge of cGMP relevant to the pharmaceutical industry
Expert knowledge with start-up and validation of pharmaceutical manufacturing facilities
Experience in Lean Manufacturing environment a plus.
Demonstrated experience and knowledge of facility and engineering operations and processes.
Strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
Experienced in directing and leading large successful organizations, building trustful and effective relationships with the ability to influence at all levels.
Possesses strong verbal and written communication skills.
Ability to think strategically and translate strategies into actionable plans.
Takes responsibility, drives results and achieves expected outcomes.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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.
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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.
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