Head of Asset Management - Drug Substance/Drug Product

South San Francisco
California, United States of America


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The Position

We are seeking a highly inspired person and an accomplished leader to lead the Asset Management Group, which will optimize Asset Lifecycle Management (ALM) by developing and maintaining engineering standards, leading asset design changes, and optimizing performance of Drug Substance and Drug Product assets. The Asset Management (AM) group is within the Facilities and Engineering (F&E) Department of South San Francisco Production (SSFP). The AM group provides Subject Matter Expertise, Plant Engineering, and cross functional Leadership and Accountability for continuous asset performance.

Responsibilities

Leadership & People Management:

  • Leader of the Asset Manager group.  Provide guidance, mentorship, and leadership to supervisors and engineers on the team. 
  • 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 Asset Management organization.
  • As a Facility and Engineering 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 AM organization.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset.
  • Administers service contracts with Engineering service providers ensuring that cost, quality and delivery to achieve the best value and manages ongoing relationships with providers.
  • Ensure SHE and cGMP Compliance for all Engineering functions
  • Presents and participates in the industry-wide collaborative efforts (e.g. ISPE, PDA, AIChE) as relates to all aspects of the System Class design, installation, commissioning, operation, maintenance / inspection

Technical:

  • Ensure the delivery of innovative and cost effective designs for various asset improvements.
  • Ensure projects are delivered according to agreed upon scopes, budgets, and schedules and the work is controlled within these limitations.
  • Establish and enforce corporate engineering design standards and guidelines, including compliance with cGMP and local design requirements.
  • Stays abreast of developments in code and regulatory issues at the local level for impact to company operations and ensures that all facilities comply with these regulations and cGMP requirements.
  • Develop and implement project prioritization process taking into consideration inputs such as asset performance indicators, production schedule, compliance, safety and evolving business needs.
  • Manage the project prioritization based on the results of asset performance indicators, production schedule, compliance, and safety factors.
  • Development of innovative new methods for measuring/evaluating Asset Key Performance Indicators (KPIs) including performance, reliability, and up-time. 
  • Oversee and refine collaboration processes between the Asset Management group, Operations, Validation, Process Engineering and Quality.
  • Ensure seamless support for complex equipment issues for timely resolution (minimizing impact to operations), by supporting ongoing troubleshooting, and follow through on long term asset changes
  • Lead effort for creating and delivering equipment training to the operators on the floor.
  • Lead retention and growth of Asset knowledge and expertise
  • Accountable for life cycle maintenance of critical process requirement documents (e.g. Process URS, Process FS)
  • Accountable for correctness of critical documentation (e.g. specifications, data sheets, calculations, P&IDs / PFDs, Vendor Drawings and Turn-over Packages) that may affect the System Class performance and integrity.
  • Coordinates Systems’ status, availability, and impact across all relevant projects and activities that may affect the system in technical, cost or schedule related manner
  • Provides oversight and approval to multiple projects implementation steps as it relates to the Asset Classes
  • Accountable for continued development, retention and management of Asset specific knowledge within the AM organization. 

Requirements

  • Bachelors Degree in Science or Engineering discipline, Graduate or higher-level Degree is preferred
  • 12+ years work experience in the pharmaceutical or related industry
  • 5+ years people management experience (preferably leading other leaders)
  • 4+ years facilities management, engineering or related experience in the pharmaceutical industry
  • Extensive experience working in a cGMP environment
  • Strong ability to install systems and processes to work collaboratively across functions, including visual management tools to monitor performance
  • Strong knowledge of project management
  • Possesses strong verbal and written communication skills and the ability to influence at all Ievels.
  • Expert knowledge of cGMP relevant to the pharmaceutical industry
  • Builds trustful and effective relationships
  • Capable of providing creative, out of the box approaches to design and operating challenges

Work Environment/Physical Demands/Safety Considerations

  • Work in a standard office environment and clean room environment.
  • Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
  • No makeup or jewelry can be worn when working in the clean room environment.
  • Work in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
  • Work with hazardous materials and chemicals.

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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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