Global Head, Biologics Pharmaceutical Development

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.

The Position

***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.

The Opportunity

You, the Global Head of Biologics Pharmaceutical Development, set the strategic direction of the Organization globally and drive effective delivery outcomes contributing to Pharma Vision, R&D effectiveness and efficiency, and PT North Stars. You will lead end to end pharmaceutical development from biologics molecule assessment to marketed drug product presentations and the development of new drug delivery technologies, pharmaceutical processing, and engineering.

You will work closely with peer global leaders of Biologics Drug Substance Development, Biologics Analytical Development and Quality Control (ADQC), and Biologics Clinical Manufacturing and Supply 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 partners, and effective leadership of our Technical Development community locally and globally.

You also play a central role in collaborating with Roche Pharma’s Cell & Gene Therapy Development organization, and 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.

You will build and sustain a high-performing organization fostering 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), Chugai, Global Product Development (GPD), Global Product Strategy (GPS), Partnering, 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 have a passion for collectively leading PTD into a best-in-class 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.

Lead an organisation consisting of 170+ specialists and scientific staff based in South San Francisco (US) and in Basel (Switzerland) and are accountable for a portfolio that consists of approximately 50+ development projects and second generation of commercial products in a variety of therapeutic areas including immunology, ophthalmology, oncology, neuroscience, and metabolism.

Key Responsibilities and Accountabilities:

• Develop and preside over the implementation of all activities related to Pharmaceutical Product development for all pipeline products in the Pharma Technical Development Biologics portfolio.

• Provide strategic leadership and commit to the scientific excellence of the formulations and stability efforts to support early and late stage clinical studies, commercial launch and significant post-market modifications. This includes:

  • Developing robust formulations and manufacturing processes

  • Developing new technologies & innovative drug delivery approaches enabling future products, such as ocular products, co-formulated products, sustained release products and more patient focused dosage forms

  • Identifying, prioritizing & overseeing formulation and DP processing technology development efforts in line with mid to long term business objectives and their conversion into mainstream approaches

  • Provide oversight of the execution of drug product process characterization and validation programs in preparation for licensure with a focus on right the first time

  • Oversight of equipment development and qualification activities

• Provide strategic leadership for molecule assessment in partnership with counterparts with Research & Early Development (gRED/pRED) organization, Analytical Development, and Drug Substance Development

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

• Ensure capabilities and expertise is available to support all Drug Product programs.

• Provide scientific and business strategies to project teams and the Technical Research & Development community.

• 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

• Collaborate effectively with partners in Device Development, Global MSAT and Global Product Strategy in developing aligned strategies and concepts for the development of drug product, drug delivery and devices.

• Build and maintain effective collaboration with gRED, pRED/LMR, PTD, GPD, GPS, and PT (Commercial Manufacturing, CGT, Quality, Supply Chain. Regulatory) to ensure seamless product development, process and knowledge transfer to clinical and commercial manufacturing operations and technical lifecycle management with a focus on continuous improvement and productivity, providing ongoing support where appropriate

• Cultivate compliance culture and instill internal and external requirements in all aspects of product development including cGMP and SHE

• Improve our business and deliver PT R&D budget by using financial insights and deliver PTD commitment (FTEs, Direct Expense, PVCs, Capex).

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

• Practice collective leadership with peer Technical Development function heads to ensure valued 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 the Late Stage Technical Development Committee (LSTDC), and Early Stage Portfolio Committee (ESPC) and other global governance bodies as appropriate (e.g. Technology Portfolio Committee, CAPEX Committee)

Who You Are

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 R&D community. 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.

• Ph.D. degree (preferably in Life Science or engineering) or equivalent work experience, and a minimum 15 years relevant experience in the pharmaceutical or biopharmaceutical industries, including 5 years leading highly technical organizations preferably in Pharmaceutical industry. (Pharmaceutical Development, Manufacturing Science and Technology, CDMO, etc.)

• Consistent track record 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 inclusive cultures 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. History 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 ability to successfully lead 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 sound judgment and decision making framework

• Outstanding knowledge of FDA 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. History 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 proficiency. 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.

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.

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.