Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche’s groundbreaking therapies to millions of patients worldwide. PT is involved in producing every Roche medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche medicines in all disease areas and dosage forms.
Pharma Technical Development (PTD) is an integral part of this mission. As an organization of over 2,500 people globally, PTD is responsible for developing the manufacturing processes, products, analytical methods, and Chemistry, Manufacturing & Controls (CMC) strategies to deliver all new products in Roche’s pipeline. This work encompasses the full range of development functions, including biologics, synthetic molecules, devices, clinical supply chain management, and project and portfolio management. PTD applies leading technical expertise to design, develop, supply, and register clinical-stage products globally, reliably delivering the pipeline and supporting commercial manufacturing operations. We excel through innovation, collaboration, dedication, and mutual respect, continuously improving what we do to ensure Roche’s supply of quality products to patients. We commit ourselves to scientific rigor, technical excellence, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
The Global Head of Project and Portfolio Management will provide strategic and operational leadership for Chemistry, Manufacturing & Controls (CMC) across the R&D organization. You will define and drive the global CMC development portfolio and strategy, ensuring alignment with corporate priorities, scientific innovation, and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders (CMC leaders) responsible for delivering high-quality, timely CMC packages to advance the pipeline from early development through commercialization.
Key Responsibilities
CMC Strategy & Leadership
Establish and lead the global CMC development strategy in alignment with One Pharma Strategy and R&D Excellence objectives.
Anticipate and integrate industry, regulatory, and scientific trends into CMC approaches and portfolio decisions.
Provide scientific, technical, and business leadership to guide critical CMC development programs.
Portfolio Management & Execution
Develop, enhance, and oversee CMC portfolio governance, prioritization, and decision-making processes effectively such as Late Stage Technical Development Committee (LSTDC).
Ensure timely and efficient delivery of CMC packages supporting IND, CTA, IMA/BLA/NDA, and global submissions.
Drive portfolio insight and performance analytics to optimize resource allocation and execution.
Lead the creation and use of standard systems, tools, and processes to enable analysis and management of the technical development portfolio (e.g. 100 people years, RDE DevGo to EIH goal).
Project & Program Leadership
Manage CMC strategies, risks, and overall project execution to efficiently deliver robust manufacturing processes and materials within requested timelines and budget
Partner with R&D, regulatory, quality, clinical, and commercial & PT stakeholders to ensure seamless development collaborations and execution.
Champion a culture of operational excellence, accountability, and proactive risk identification and mitigation.
Team Leadership & Talent Development
Lead, inspire, and develop a team of technical development leaders (TDLs) delivering the projects by working with functions such as drug substance, drug product, analytical development & quality control, device and delivery, regulatory CMC, manufacturing sciences, and clinical and commercial manufacturing sites. Act as a coach for teams.
Recruit, retain, and develop high-potential talents for the Technical Development Leaders (TDLs) and Project Managers. Foster a high-performing, collaborative, and inclusive culture.
Build organizational capabilities to meet evolving portfolio and industry needs.
Leadership Team Contribution
As a member of the PTD leadership team, contribute to the team’s high performance, foster cross-functional thinking, and work collaboratively to set priorities for the global organization.
Stakeholder Engagement and Communication
Ensure a strong connection to key stakeholders within the broader global project team system (e.g., Lifecycle Teams, gRED & pRED project Teams).
Partner with R&D, regulatory, quality, commercial stakeholders, and Roche Partnering to ensure seamless development transitions and alignment.
Enable open and timely communication with senior management regarding CMC issues and resolutions. Facilitate project status reports, governance committee briefings, and project updates to management.
Advanced degree (Ph.D. preferred) in chemistry, biology, engineering, pharmaceutical sciences, or related discipline.
Extensive years of progressive and inspiring leadership in CMC development, manufacturing sciences, or related R&D functions, with proven success and a long track record.
Deep knowledge of global regulatory requirements, product development processes, and CMC and/or product lifecycle management.
Demonstrated ability to grasp the changing and dynamic external environment to shape strategy, manage complex portfolios, and deliver across early and late-stage development.
Exceptional leadership capabilities, excellent communication-, and influencing skills in effective engagement with leaders and stakeholders across R&D and PT. Ability to positively influence colleagues and key decision-makers.
Strong business acumen and collaboration skills, with the ability to balance scientific, operational, and strategic priorities in a global organization.
Experience in team leader development, project portfolio management, and developing business processes and tools to support a global team system.
15-20% international travel required.
Strategic and innovative thinker with a global mindset.
Strong decision-making and problem-solving skills in complex, fast-paced environments.
Track record of building and leading high-performing, inclusive teams, passionate about talent development.
Highly collaborative, able to influence and align across all levels, internal stakeholders, and external partners.
Commitment to quality, compliance, and patient-centric innovation.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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