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The Position
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which produce millions of units of life-saving medicine every year for patients around the world. This exciting role resides in the Parenteral Launch and New Technology Value Stream (PLaNT) organization and is responsible for introduction of new products (technical transfers),and implementation of new technologies at our manufacturing site in Hillsboro, OR. The Opportunity: As the Tech Transfer/Launch Lead in the PLaNT organization, you will serve as a project lead for new product tech transfers, launches, site to site transfers, technical investments, divestments and other projects.
You will be responsible for planning, coordinating and executing tech transfers, and other projects across various technologies (biologic Drug Product, Finished Goods, combination products) in collaboration with local and global partners, while taking ownership of key project milestones. You will build and lead local project teams, serving as a servant leader and organizing and prioritizing critical issues and information to facilitate robust decision-making. You will manage resource and budget planning for projects, support sourcing decisions, and site selection process, while acting as a site tech transfer lead for new product launches to ensure smooth product launch. You will ensure transparency and proactive communication within the team and with local and global partners, overseeing change control in respective projects. You will bring strong matrix team leadership skills, adept in partnering with local and global networks collaborating closely across the Pharma Technical Group to meet project objectives including process control strategy, tech transfer plan, FMEA, PPQ protocols, authoring regulatory filing documents and handover to manufacturing value streams. You will build subject matter expertise in tech transfer at the site level through coaching, mentorship, and development of programmatic approach. You will collaborate with partners to develop comprehensive validation strategies and ensure smooth execution, while striving for significant improvement and reduction of project timeline and costs, establishing lean and robust processes. You will focus on industrialization aspects in executing tech transfers and implementing new technologies, and planning in collaboration with sponsors and stakeholders. You will facilitate a "right first time" mindset within the team and role model an agile mindset.
Who you are:
You have a Bachelors degree in Pharmaceutical Sciences, Life sciences, Engineering You have deep, relevant bio/pharmaceutical experience (12-15 years), specifically in leading tech transfers for Parenterals You have deep knowledge of cGMP and Regulatory expectations for Pharmaceutical products. You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution. You have an ability to demonstrate creative leadership skills as a Visionary, Architect, Catalyst, and Coach (VACC), removing barriers, developing people and technical capabilities, and creating an environment for high performance. You are solution-oriented and can-do attitude, fostering organizational success. You have experience supporting the advancement of diversity, equity, and inclusion.
The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $112,000 - $209,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Link to Benefits Relocation benefits are provided #gnehtoengineers Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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Genentech
Nov 24, 2024