Head of Downstream Manufacturing

California, United States of America

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The Position

The Head of Downstream Operations 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 manufacturing. This position ensures network demands are met, safely, in adequate time and quantities, always seeking for balance between quality, competitive cost and time for manufacturing.

Key Responsibilities/Tasks:

  • 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 site.
  • As a manufacturing 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 manufacturing in coordination with the Site Head.  
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset.
  • Ensure manufacturing of quality products according to Health Authority requirements, Roche PQS, including DMS, CAPA, QRM, and TCM.
  • Optimize manufacturing 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 manufacturing, productivity, and financial goals and manage operations so that all site goals are met.
  • Ensure cGMP compliance and inspection readiness for site at all times. Actively support inspection activities.
  • Ensure the condition of all equipment, premises, and infrastructure at site. 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 for the area of responsibility and ensure conformance with production schedules.
  • Responsible for IPC analysis and ensuring that the planned production in the area of responsibility can run without delay.
  • Further develop the operating procedures and equipment in the area of responsibility 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 area of responsibility in defining and refining validation strategy, investigations and technical transfers.
  • Continuously monitor deviations in the area of responsibility and define and implement sustainable measures to reduce deviations. Promotes problem identification and a culture of proactive problem prevention.

Qualifications (education/experience/knowledge/skills/competencies)

  • Bachelors Degree required (science or engineering is preferred); additional requirements may be specified by site and local needs. --> modular setup needed to meet site specific needs (e.g. pharmacists for MH)
  • Graduate or higher-level Degree is preferred
  • Manufacturing Professional certifications is preferred
  • 5 or more years’ work experience in the pharmaceutical or related industry
  • 3 or more years’ people management experience
  • 4 or more years’ manufacturing/production or related experience in the pharmaceutical industry
  • 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.
  • Capable at building 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.

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.

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