Manufacturing Analytics Specialist, Process and Compliance

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Organization Overview

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 combine to produce millions of units of life-saving medicine every year to patients around the world.

Job Summary

This position is located at Genentech's Hillsboro Technical Operations facility (HTO) in Hillsboro, Oregon. Under the direction of the Process & Compliance Lead, this position will focus on providing day-to-day operations support for our Aseptic Filling Operations. As a Analytics Specialist, you will play a crucial role in ensuring the smooth and efficient operation of our aseptic filling processes, while maintaining the highest quality standards. You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements.

The qualified candidate applies expertise in building business informatics systems and data analytics to monitor business results and inform decision making. This individual will participate in a variety of initiatives and projects to address business challenges and unmet needs that apply across the Value Stream organization and support functions. This is a hands-on role and the successful candidate will be comfortable working in an agile environment and is capable of leading data projects at pace and interfacing with a wide variety of site and network stakeholders.

Key Responsibilities:

• Manage the development and implementation of novel approaches to solving complex operational problems while maintaining required levels of safety, quality (including regulatory compliance), and production. Provide support on projects related to manufacturing operations.

• Interprets customer functional and informational needs and turns them into data requirements, process models, and active, functioning systems.

• Builds analytical tools, using multiple data sources, to automate data analytics and business performance indicators.

• Provides data science guidance to afford product owners with the ability to access, analyze and visualize data relevant to business decisions

• Maintain quality of the data using customer feedback, concerns, questions; developing reporting metrics; evaluating and identifying issues; and coordinating and implementing corrections regularly

• Executes projects, with appropriate guidance, allowing for identification of insights and improvement opportunities across the Value Stream-centric organization, that ultimately derive business value for HTO

• Collaborate and support Technology and Quality in resolving investigational issues. Support resolution of discrepancies particularly as related to operational and process issues (CAPAs/ Quality Excursions).

• Drive business process improvements that significantly enhance customer satisfaction, improve quality system robustness, process capability, equipment reliability, and overall process efficiency.

• Drive continuous improvement - Continuously monitor and further drive the quality and availability of data also in alignment with other business units and functions

• Delivers effective and clear communication of issues / data to stakeholders

• Work closely with any teams for relevant digital initiatives to ensure relevant data is fit for purpose to support the digital evolution of HTO.

• Continually learn new analytical skills, techniques and tools to maximize competitive advantage; participate in internal & external technology communities

• Builds visual factories and production activity control boards

• Develop and execute data trainings for the organization

• Optimize workflows and communications

Qualifications:

• Excellent written and verbal communication skills along with a strong desire to work in multifunctional teams.

• Results-oriented, diligent and has a sense of urgency. Assertive, responsible for his/her own (self-directed) work, and is willing to commit to deadlines.

• Proven ability to operate effectively in a global, matrixed, cross-functional environment with site, functional, and executive leadership.

• Proven track record of working with large datasets (both structured and unstructured), presenting that data in meaningful ways and deriving actionable insights; presenting insights back to stakeholders.

• Experience in building and optimizing 'big data' data pipelines, architectures and data sets.

• Experience with data visualization tools, data wrangling tools, and with relational or NoSQL databases.

• Enthusiastic and energized about data and be driven to share that knowledge and excitement with others.

• Able to understand various data structures and common methods in data transformation.

• Proven experience of effective stakeholder management and strong influencing skills where there is not direct management control.

• Strong analytical thinking, result-oriented team player and ability to prioritize and organize work effectively.

Education and Work Experience:

• Bachelor's Degree in Business Informatics, Data Science, or Engineering with some experience in building business information systems.

• Previous experience in biotechnology or pharmaceutical manufacturing with understanding of cGMP principles is a plus.

Relocation benefits are provided

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.