Global Head, Biologics Clinical Manufacturing and Supply

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

***Please note that equal consideration will be given to candidates for any of the listed site locations.***

Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche’s groundbreaking therapies to 127 million patients around the world. 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 production of Roche medicines in all disease areas and dosage forms.

Pharma Technical Development (PTD) is integral to Roche’s mission to develop innovative and transformative meaningful medicines for patients by applying leading technical expertise to design, develop, supply, and register clinical stage products globally. .

You, the Global Head of Biologics Clinical Manufacturing and Supply, are responsible for setting the strategic direction of the Organization globally and for driving effective delivery of outcomes contributing to Pharma Vision, R&D effectiveness and efficiency, and PT North Stars. You will lead the Biologics Clinical Supply Network which translates newly developed Drug Substance and Drug Product processes to GMP clinical supplies to deliver high quality parenteral clinical supplies from Phase 1 up to Launch, including providing and improving manufacturability during development of new processes.

You will work closely with peer global leaders of Biologics Drug Substance Development, Biologics Pharmaceutical Development and Biologics Analytical Development and Quality Control (ADQC) to collectively deliver on our Global Biologics Technical Development aspirations. This includes shared accountability for the cross-functional operating model to effectively deliver the full Biologics pipeline from early stage development through licensure and launch, seamless engagement end-to-end with Biologics collaborators, and effective leadership of our Technical Development community locally and globally.

You also play a central role in collaborating with other PTD functions such as Synthetic Molecule Development, and Device and Packaging Development. The organization is also responsible for providing technical support and oversight at CMOs and internal manufacturing sites for technology transfers, launch, and commercial products for clinical use.

You will build and sustain a high-performing organization fostering an environment of inclusion, innovation, collaboration, and people engagement. You will foster partnerships across the Pharma value delivery chain in Roche Early Research and Development (gRED/pRED/CiCOR), Global Product Development (GPD), , and Pharmaceutical Tech Operation (PT). You will be a member of the PTD Leadership Team and partner closely with PT Biologics R&D functions to deploy Pharma and PT strategies needed to effectively and efficiently deliver the company’s exciting, large, and diverse pipeline. You are passiona for collectively leading PTD into an elite development organization and being the benchmark for the industry. As a successful candidate, you have a demonstrated track record in developing the future leaders. You practice VACC (Visionary, Architect, Catalyze, and Coach) and Lean Leadership, and are a role model for the PT community leaders with respect to performance, collaboration, organization development, and business outcomes.

You will lead a team consisting of 400+ experts and operations staff based in South San Francisco (US), Basel (Switzerland), and Penzberg, (Germany) and are accountable for a portfolio that consists of approximately 50+ development projects in a variety of therapeutic areas including immunology, ophthalmology, oncology, neuroscience, and metabolism.

Key Responsibilities and Accountabilities:

• Develop, implement and oversight of Biologics DS and DP Clinical Supply Network strategies and operations for all pipeline products in the Pharma Technical Development Biologics portfolio including:

  • Efficient manufacturing of high quality clinical supplies

  • Maintaining high SHE and GMP infrastructures and compliance. Establishing engrained GMP mentality

  • Pioneering and contributing to progress of new manufacturing technologies with focus on implementation in a GMP environment.

• Provide strategic leadership and aim for excellence within the CSC Network to develop and deliver clinical supplies needed for early and late stage clinical studies

• Connect and collaborate with partners in Roche and externally to leverage knowledge, learn and influence conversations that affect PTD

• Commit to digital transformation to accelerate the development of product and process knowledge and to convert data to new product & process insights.

• Ensure capabilities and expertise to support all Clinical Supply Operations today and in the future

• Translate strategy into action: Inspire and lead others to communicate and act with a clear vision and purpose, connecting different perspectives; drive execution of strategies across PT and R&D community

• Ensure close alignment and effective collaboration with key internal partners including gRED, pRED/LMR, CPMF, Commercial DP and DS sites, Quality, Regulatory, Supply Chain, PTD Biologics Technical Development departments, Technical Development Teams, and the rest of Technical Development to ensure seamless Clinical Supply delivery, manufacturing process and knowledge transfer to commercial manufacturing operations.

• Cultivate compliance culture and instill internal and external requirements in all aspects of Clinical Supply Manufacturing including cGMP and SHE. Participate in internal and external audits and conduct self-inspections to ensure continuous improvements

• Improve our business and deliver PT R&D budget by using financial insights and deliver PTD commitments (FTEs, Direct Expense, PVCs, Capex). Be an advocate and champion for Sustainability and Inventory Reduction.

• Engage PTD in continuously improving productivity, performance and striving for excellence in development of biologics. Actively practice LEAN and to continue to improve quality metrics. Leverage Lean Leadership to improve the system, process, efficiency, and capability in the organization and to accelerate the learning.

• Practice collective leadership with peer Technical Development function heads to ensure effective leadership of the Biologic global community as well as the South San Francisco, Basel, and Penzberg Technical Development communities

• Chair or Co-chair the Early Stage Technical Development Committee (ESTDC) for biologics, Large Molecule Technical Reviews (LMTR), and serves as a member of Late Stage Technical Development Committee (LSTDC), and a member of Early Stage Portfolio Committee (ESPC) and other global governance bodies as appropriate (e.g. Technology Portfolio Committee, CAPEX Committee)

Qualifications & Experience:

The leader must be customer focused and have a strong commitment to embracing network people capabilities and working collaboratively to advance Roche portfolio. As such, the leader will foster an environment of cross-functional collaboration, accountability, and technical rigor in collaboration with the Technical Operations and R&D communities. The successful candidate will have a demonstrated track record in recruiting and developing diverse leaders and being a good business and financial steward. The individual will provide active, visible leadership in advancing the portfolio and ensuring a positive external reputation.

• Higher education (preferably in Life Science or Engineering) or equivalent work experience, and a minimum 15 years relevant experience in the pharmaceutical or biopharmaceutical industries, including 10 years of leadership experience

• Technical expertise in end to end biologics development. Experience in supporting clinical development & regulatory submissions and a working knowledge of regulatory guidelines for commercial filings. Experiences in Biologics Parenteral Manufacturing is highly desirable.

• History of developing diverse, high performing organizations and teams with high standards for scientific excellence, driving innovation and operational effectiveness including safety, quality, compliance, and continuous improvement. Fosters inclusivity to ensure different perspectives, experiences, and knowledge are valued.

• Sets high standards and role models excellent people leadership including. coaching, talent development and performance management. Consistent record of developing people and technical leaders.

• Excellent communication skills with the ability to connect with and inspire staff at all levels and encourage direct and open dialog. Ability to convey controversial information and decisions as appropriate.

• Demonstrated success leading complex organizations (e.g. multi-sites, multi-functional, etc), including people, financials and business processes and to provide focus and direction to navigate in fast moving environment

• Extensive knowledge and experience in multiple facets of technical development with demonstrated sound judgment and decision making framework

• Outstanding knowledge of FDA, EMA, and ICH regulatory guidelines and standards for biopharmaceutical process development and manufacturing and cGMP and SHE requirements practices

• Demonstrated customer and collaborator focus with strong relationship management. Track-record of driving value through effective collaboration across multiple interfaces between technical, manufacturing, quality, regulatory and clinical functions. Ability to positively influence multi-disciplinary teams.

• Strategic with a broad understanding of the internal and external environment and application to strategy development. External influence is highly desirable such as experience leading external collaborations with partner companies, CMOs and academic institutions.

Roche commits to recognizing talent and competence. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.

We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be!

Relocation benefits are available for this job posting.

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.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. 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.

Roche is an Equal Opportunity Employer.