South San Francisco
California, United States of America
Location: South San Francisco
REPORTS TO: Global Head, Biologics/ADC External Development Collaborations
ORGANIZATION: Pharma Technical Development External Development Collaborations
Who We are
At Roche, 85,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare companies. Our success is built on innovation, curiosity and diversity. The headquarters in Basel is one of Roche’s largest sites, over 9,500 people from approximately 90 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.
Within the External Development Collaborations group, we are a global function that delivers external solutions for the Genentech and Roche Research Early Development pipelines. We ensure the delivery of clinical materials to patients and much more. Our functional group is based in South San Francisco.
This position will have the primary responsibility of ensuring the successful development and execution of Genentech’s and Roche’s early and late-stage clinical ADCs, Biologics and Novel Technologies for Drug Substance (DS), Drug Product (DP) and Chemistry Manufacturing Controls (CMC) outsourcing activities to contract manufacturers (CMOs) and contract service providers (e.g. CROs).
The candidate will be Roche’s key interface between our internal functions, external business partners and CMO’s project teams.
They will lead a cross-functional team of Subject Matter Experts (SMEs) throughout the lifecycle of our clinical contract manufacturing relationships to direct, coordinate and oversee all technical, operational, supply chain, quality and business activities required to select, transfer, start-up and oversee the successful, timely delivery of clinical trial materials (CTM) and other CMC services from our CMOs and contract service providers.
The candidate will guide decisions in shaping Roche’s outsourcing strategies to complement in-house development capacity and capabilities, which will support the extensive Pipeline portfolio.
They will perform feasibility assessments, evaluate risks, costs and analyze the outsourcing landscape against internal current and future needs (i.e. in-licensing projects). This will include assessing various markets (e.g. China) and CMOs/CROs for manufacturing, development and analytical testing capabilities. Specific responsibilities of this position include: * Conduct due diligence activities for in-licensed Genentech and Roche Research and Early Development (gRED) and (pRED) compounds, and for new CMOs for future work.
* Lead and drive the selection process for CMOs and other outsourcing partners in collaboration with Technical Development Teams (TDTs).
* Serve on the TDTs as the Joint Management Team (JMT) Leader, leading and overseeing activities at the contract service provider.
* Lead the cross-functional JMT charged with managing the technology transfer and development/manufacturing/testing activities at the contract service provider.
* Provide a single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.
* Develop and manage mutually beneficial, long-term business relationships with CMOs.
* Lead and/or support department business initiatives and facilitate their implementation, including developing and/or improving phase-appropriate business processes across the contract manufacturing lifecycle in collaboration with key stakeholders and operational excellence groups.Who you are:You are someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. You want to be where a job title is not considered the final definition of who you are, but the starting point of your potential.The ideal candidate will have the following skills and qualifications:* BS in the relevant Engineering or Life Sciences field discipline is required. An advanced degree (MBA, MS, or PhD) is desired. * Minimum of 10-12 years biotech/pharmaceutical industry experience in manufacturing/process development or supply chain management is required. Specifically, experience working with process development groups along with overall knowledge of clinical manufacturing, regulatory, QA, and cGMP requirements for biological products is desired. * Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions. * Demonstrated ability to operate within a matrix organization and to manage multiple organizational interfaces and stakeholders. Ability to set and achieve aggressive milestones through cross-functional teams.* Must have strong project management, organization, facilitation, problem solving and quantitative analysis skills; strong financial management skills are a plus. * Experience developing, negotiating and administering clinical or commercial contract manufacturing / supply and/or quality agreements is preferred.* This position may require up to 25% domestic and international travel.
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.
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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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