Site Platform Industrialization Lead

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The Position

The Kaiseraugst production site is a cornerstone of Roche's global production and logistics network. Over 1900 people are employed here and the site is home to Roche's largest and most innovative packaging operation in the world. Parenteral Launches and New Technology Stream (PLANTS) is responsible for Introduction of New Products (Technical transfers) and Implementation of New Technologies on our manufacturing site in Kaiseraugst. Our pipeline of new combination products and new devices is growing, so we need to ensure we are building the right capabilities for the future.

The Site Platform Industrialization Leader is an individual contributor and local matrix leadership role which

• supports the global technical Platform team within Device and Packaging Development/Global Device MSAT responsible for developing, adapting, and maintaining a global device and packaging lifecycle strategy for AI/PFS NSD platform and associated development projects with a 5-10 year planning horizon.

• leads a local cross functional team responsible for industrialization of AI/PFS NSD Platform on site including both implementation and life cycle

The primary focus of this position will be AI /NSD PFS platform industrialization. With time , responsibility may evolve to cover other platforms or devices.

Key Responsibilities/Tasks

• Build and manage a cross functional technical team at manufacturing site capable of supporting clinical and commercial platform device combination product development and platform lifecycle

• Responsible for E2E AI/NSD PFS Platform clinical manufacturing and industrialization at site, ensure alignment between associated functions at site, alignment between single projects and other platform goals.

• Support global platform goal-setting and collaboration within the global platform team.

• Oversee assessment and mitigation of platform risks, including contingency plans and investments as needed to support manufacturing capacity and new technology introductions.

• Provide input to the platform team about Internal Manufacturing capabilities

• Member of relevant governance committees

• Share communication related to the platform strategy and planned activities across the KAU site

• Support to develop and execute a multi-year platform product roadmap, including IP strategy.

• Contributes to objective setting and performance management activities for team members in the platform team, drives standardization, process improvement and efficiency for platform

• Building networks and collaborating with key senior level partners, including VS Leads, Site Leadership Team , Pharma Technical Operations Technology (PTT), Pharma Technical Development (PTD) and Pharma Technical Manufacturing (PTM) leaders.

Who you are

You hold a B.S./M.S/Ph.D. degree in science, engineering, or a related field and you have strong technical expertise, minimum of 5 years of relevant device industrialization or device development experience ideally as matrix leader

Knowledge/Skills/Competencies

• Proven ability to lead and align an organization for complex technical projects; experience developing/realizing a vision and multi-year strategies for device platform Technologies.

• Ability to collaborate with internal/external senior-level clinical, commercial, and technical stakeholders.

• Advanced expertise in product lifecycle management for complex systems (e.g., managing platforms and custom solutions, integrating market feedback and business needs into product lifecycle roadmaps, etc.)

• Advanced level of coaching mindset (e.g., high emotional intelligence, ability to give candid and actionable feedback), verbal and written communication skills, including ability to define and articulate team deliverables

• Servant leadership – removing barriers for team members and functional innovation teams

• Proven ability to lead in matrix —able to inspire and motivate teams to make a big impact and deliver their best every day. Track record of having the courage to drive change, while balancing risks and pacing for success.

• A fundamental, working understanding of safety, quality systems, and quality assurance concepts are required including the application of current Good Manufacturing Practices (cGMPs).

• Advanced analytical skills and financial acumen: capable of analyzing financial, quantitative, and/or qualitative data and translating into high-impact learnings and recommendations.

• Fluent English and advanced German knowledge is a must

Who we are

At Roche, more than 100,000 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.

Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.