Considered the founder of the biotechnology industry, Genentech has been delivering on the promise of biotechnology for more than 30 years, using human genetic information to discover, develop, manufacture and commercialize medicines to treat patients with serious or life-threatening medical conditions. Today, Genentech is among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
In March 2009, Genentech became a member of the Roche Group. As part of their merger agreement, Roche and Genentech combined their pharmaceutical operations in the United States. Genentech's South San Francisco campus now serves as the headquarters for Roche pharmaceutical operations in the United States. Genentech Research and Early Development operates as an independent center within Roche.
Post: Principal Technical Manager, Supplier Collaborations
Job Description:
• Lead process improvement projects at Supplier sites to ensure reliable Direct Material* supply
• Collaborate with cross functional representatives and Supplier representatives to bring comprehensive solution to trending and recurring Direct Material* issues
• Proactively address anticipated issues using Quality Engineering tools to effectively support new Supplier site introductions, Supplier site transfers, new technology introduction at Supplier site
*Direct Material refers to raw and starting materials, purchased API, excipients, packaging etc. used in and for Roche product manufacture and TR&D.
Duties/Responsibilities:
• Lead projects to provide solutions to process and material quality problems with reference to regulatory requirements and Roche expectations; in collaboration with Direct Material suppliers and internal Business Partners and stakeholders.
• Troubleshoot and direct the resolution of Direct Material Quality issues by fostering effective interdepartmental and cross-functional partnerships and applying Quality Engineering, Process Engineering and Operational Excellence tools internally and at Supplier sites.
• Provide Quality Engineering support in projects related to Direct Material supplier site transfers, new supplier due diligence, and new technology start-up.
• Develop project plans and establish work priorities to meet targets and timelines.
• Identify, design, and implement process and system improvements.
• Apply technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems related to chemical, biological, medical devices, and non-formulating materials.
• Serve as a trainer and train internal personnel (as needed) on Process Engineering, Quality Engineering and Operational Excellence tools.
• Collaborate and author department policies and procedures.
• Be able to make decisions using a collaborative and cross-functional process, in accordance with the Roche Decision Making model.
• Be able to apply good judgment and notify and escalate to Management potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Author and review technical reports as a result of Supplier Collaborations projects
• Be accountable for behaviors as described in Roche’s Core Values.
• Set personal performance goals and provide input to departmental objectives.
• Manage competing priorities.
• Educate suppliers on Roche quality requirements and drive “zero defect” mindset among suppliers.
• Responsible for appropriate use of departmental resources
• Perform, in a timely manner, any other tasks as requested by Management to support Supplier Quality oversight activities of chemical, biological, medical devices, or non-formulating material suppliers.
• Serves as consultant to management and internal/external spokesperson for the organization on matters pertaining to its policies, plans, objectives and business operations.
• Provide guidance and manage work activities of other staff members for specific projects or objectives (as applicable).
• Contribute to overall objectives, short- and long-range goals of the organization.
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Technical Duties/Responsibilities:
In partnership with Roche’s Direct Material suppliers and internal Supply Chain Direct Material Management groups, to ensure uninterrupted supply perform the following technical duties:
• Lead supplier site technical visits to review entire manufacturing processes related to manufacturing of chemicals, biological, medical devices, and non-formulating materials.
• Assess Process Capability of Supplier processes; Track, update, and report all relevant KPIs.
• Lead and drive process improvement activities at Supplier sites and internal sites (as appropriate) to achieve reliable Direct Material supply
• Manage suppliers’ performance to ensure there are no regressions with the implementation of agreed upon activities/improvements
• Participate in supplier Risk Assessments, and Supplier Analysis with Procurement (as applicable)
• Lead and / or participate in Business and performance review meetings (as applicable)
• Train personnel on Quality Engineering, Process Engineering and Operational Excellence tools.
• Write and review technical reports
• Design and issue supplier Business and Quality reports as required
• Investigate, analyze and resolve non-conformities relating to product, process, and quality systems by conducting deep dive assessments, analyzing defect trends and leading continuous improvement projects.
• Champion problem solving and root cause analysis activities with suppliers to eliminate recurrence of non-conformances.
Education, Experience, Knowledge and Skills:
• University degree in Pharmacy/Chemistry/ Engineering/ Biochemistry and at least 12 years of demonstrated ability and experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
• Sound knowledge of cGMPs, ISO standards and international regulations
• Ability to interpret and relate Quality standards as they relate to Roche and Direct Material suppliers
• Ability to make sound quality decisions with an End-to-End (E2E) approach
• Ability to communicate clearly and professionally both in writing and verbally, in English
• Ability to build relationships cross functionally and with outside companies
• Project management experience and the ability to lead complex projects and cross functional team members
• Possess proven negotiation skills and the ability to influence Roche’s suppliers and internal groups
• Knowledge and experience in at least two of the following: drug, medical device, or biologic manufacturing processes, Supplier Quality, laboratory test methods, sterilization, and validation processes
• Knowledge of OE tools is required: i.e. statistical methods, FMEA, Six Sigma, Lean Manufacturing
• Ability to travel domestically and internationally approximately 20%
Additional Information
Experience: 12 years
Location: United States - California, South San Francisco
Company/Division: Pharmaceuticals
Industry Type: Pharma/ Biotech/Clinical Research
Job Type: Regular Employee
Job ID: 2725598515
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