Director/ Sr Director Mfg-Pharma CCP 1- Vacaville

Vacaville, California
United States

Job ID: 2566528251

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The Position

The Head of Manufacturing CCP1 – upstream/downstream is accountable for the safe, cost-effective, and efficient operation of manufacturing, while in full compliance with current Good Manufacturing Practices and Roche’s corporate principles, quality policies and standards. This position ensures market demands are met, safely, in adequate time and quantities, always seeking for balance between quality, competitive cost and time for production.
 
Key Responsibilities
  • Leadership & People Management:
  • 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.
  • Establish strategic goals and objectives and maintain full strategic responsibility for the organization.
  • As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the Manufacturing organization.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset
 
Technical:
  • 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 the 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.

 

Who You Are

Qualifications:
  • Education:
    • Bachelors Degree required (science or engineering is preferred); additional requirements may be specified by site and local needs.
    • Graduate or higher-level Degree is preferred
    • Manufacturing Professional certifications is preferred
  • Experience (may vary depending on site size/scope)
    • 15 or more years’ work experience in the pharmaceutical or related industry
    • 8-10 or more years’ people management experience
    • 10 or more years’ manufacturing/production or related experience in the pharmaceutical industry
  • Knowledge/Skills/Competencies
    • Expert knowledge of cGMP relevant to the pharmaceutical industry
    • Expert knowledge with start-up and validation of pharmaceutical manufacturing facilities
    • Possesses strong verbal and written communication skills and the ability to influence at all levels.
    • Builds trustful and effective relationships
    • Able to think strategically and translate strategies into actionable plans
    • Takes responsibility, drives results, and achieves expected outcomes

 

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.


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