0 Replies Latest reply on Apr 20, 2016 3:24 PM by sszeto@kinaxis.com

    Job Opportunity: Associate Manager, Outsourced Manufacturing - EH&S - Gilead Sciences (California, Foster City)

    sszeto@kinaxis.com Apprentice

      Responsibilities

       

      With the commitment and drive you bring to the PDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

      • Provide operational engineering support for all Contract Manufacturing sites, as needed.
      • Provide engineering guidance, as needed, for major capital expansions at CMO sites.
      • Develop and manage any Gilead-sponsored Operational Excellence programs that are nominated for implementation at any of our Contract Manufacturing sites.
      • Develop Risk Management Assessments for Contract Manufacturing partner sites and use the results to direct feedback for improvement.
      • Track, report and analyze EH&S management systems at Contract Manufacturing partner sites and assist in implementation of Corrective Actions, as needed.
      • Lead EH&S audits for Contract Manufacturing partner sites and utilize results to drive improvement and reduce risk to Gilead supply chain. Provide technical review and assessments for all environmental permits for all Contract Manufacturing sites and verify compliance with all agency requirements.
      • Provide input and recommendation regarding CMOs for materials and services. Works with line manager and outsourcing team to provide input on current vendor performance assessment system.
      • Authors relevant Environmental, Health and Safety policies.
      • Participate in teleconferences and face to face meetings with CMOs, publishes agenda and meeting minutes. Schedules meetings to communicate program changes both internally and externally as needed.
      • Participates in solving issues of high complexity.
      • Communicates issues to line manager and project team in a timely manner.
      • Experience in chemical manufacturing operations management is preferred.
      • Capital project management experience and/or certification is desirable.
      • Solid understanding and knowledge of standard environmental, health and safety procedures in a chemical manufacturing environment is preferred.
      • Solid knowledge of regulatory requirements in the US and the EU.
      • Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) is preferred.
      • Good understanding of the CMO landscape, knowledge of CMO capabilities and limitations.
      • Strong communication, negotiation and interpersonal skills a must.

       

      Essential Duties and Job Functions

      • Experience in chemical manufacturing operations management is preferred.
      • Capital project management experience and/or certification is desirable.
      • Solid understanding and knowledge of standard environmental, health and safety procedures in a chemical manufacturing environment is preferred.
      • Solid knowledge of regulatory requirements in the US and the EU.
      • Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) is preferred.
      • Good understanding of the CMO landscape, knowledge of CMO capabilities and limitations.
      • Strong communication, negotiation and interpersonal skills a must.

       

      Knowledge, Experience and Skills

       

      • 8+ years of progressively responsible experience in a pharmaceutical environment or similar with a BS in Chemical Engineering.
      • A MA/MBA degree can be substituted for 3 years of relevant experience.
      • Bachelors, Masters as an equal opportunity employer.

       

      About Gilead

       

      Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

       

      For more information, click here.

       

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