Global Head, Biologics Analytical Development and Quality Control

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 ground-breaking meaningful medicines for patients by applying leading technical expertise to bridge early-stage, late-stage and commercial product needs.

You, the Global Head of Pharma Biologics Analytical Development and Quality Control, are responsible for setting the strategic direction of the organization globally and for driving effective delivery outcomes contributing to Pharma Vision, R&D effectiveness and efficiency, and PT North Stars. You will be responsible for leading development activities for biologics analytical methods and quality control. This includes:

• The development, validation, and execution of physico-chemical, immunochemical, and biological methods for Roche’s biologics pipeline.
• Integrated analytical control strategies and systems that enable CMC development of biologic therapeutics, process development, product characterization, and drug delivery for biologic products from research (molecular assessment) through product launch.
• GMP lot release, stability, and in-process testing for all clinical products globally and deviation handling.
• Effective and efficient transfers of methods to internal and external manufacturing sites as appropriate.
• Establish phase appropriate comparability strategy in partnership with non-clinical, clinical, PK/PD, and process and product development.

You will work closely with peer global leaders of Biologics Drug Substance Development, Biologics Pharmaceutical Development 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 Synthetic Molecule Development, Device and Packaging Development and Cell & Gene Therapy 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. Specifically historical commercial product knowledge (as needed for Information Requests, quality investigations, design of comparability plans, etc.) and legacy characterization methods to support Post-Marketing commitments and comparability exercises.

You will build and sustain a high-performing and agile organization fostering an environment of inclusion, innovation, collaboration, and people engagement. You will foster partnerships with collaborators across the Pharma value delivery chain in Roche Early Research and Development (gRED/pRED), Chugai, Global Product Development (GPD), Global Product Strategy (GPS), Partnering, and Pharmaceutical Tech Operation (PT). You will partner closely with PT Biologics R&D functions to seamlessly deliver the pipeline. You will be a member of the PTD Leadership Team 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 leading PTD into a world-class development organization and being the benchmark for the industry. As a successful candidate, you are experienced in developing future leaders. You practice VACC (Visionary, Architect, Catalyze, and Coach) and Lean Leadership, and are role models for the PT community leaders with respect to performance, collaboration, organization development, and business outcomes.

You will lead a team consisting of 500+ permanent and contingent scientific employees 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:

• Provide scientific business strategies to project teams and the Technical Research & Development community.
• Have and apply a broad understanding of the internal and external environment to strategy development.
• 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.
• Accountable for CMC (Chemistry, Manufacturing and Controls) deliverables and collaborates effectively with partners in Device Development, Global MSAT and GPS in developing aligned strategies and concepts for the development of biologics drug substance, drug product, drug delivery and devices.
• Build and maintain effective collaboration with gRED, pRED/LMR, PTD, GPD, GPS, and PT (Commercial Manufacturing, CGT, Commercial and IMP Quality, Supply Chain. Regulatory) to ensure seamless product development, technology transfer, and technical lifecycle management for the development and commercial products.
• 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 lead deployment of our Lean Production System 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 functions heads to ensure effective leadership of the Biologic global community as well as the South San Francisco, Basel, and Penzberg Technical Development communities.
• 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.

Qualifications & Experience:

The leader must be customer focused and have a strong commitment to embracing network talent development and working collaboratively to advance Roche portfolio. As such, the leader will foster an environment of cross-functional collaboration, accountability, and technical excellence in collaboration with the R&D community. The successful candidate will provide active, visible leadership in advancing the portfolio and ensuring a positive external reputation.

• +15 years work experience with over 5 years experience leading large and highly technical organizations preferably in Pharmaceutical industry (Bioprocessing, Analytical and Pharmaceutical Development, Manufacturing Science and Technology, CDMO, etc.)
• PhD in pharmaceutical sciences, life sciences, biological engineering, or equivalent relevant work experience.
• Consistent record of excellence in people leadership and building, engaging and developing high performing teams.
• Demonstrated ability to successfully lead large and 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 in multiple facets of technical development with demonstrated sound judgment and decision making framework.

• Outstanding knowledge of FDA, EMA, and ICH guidelines and standards for biopharmaceutical process development and manufacturing and outstanding knowledge of cGMP and SHE requirements practices.
• Proven Leadership skills and ability to positively influence colleagues and key collaborators.
• Strong track record of collaboration and relationship management.
• Excellent communication skills, ability to communicate effectively to many levels and functions and to encourage direct and open dialog.
• Demonstrated ability to be customer and partner focused, working collaboratively and across boundaries.
• Ability to think strategically and effectively communicate; able to convey controversial information and decisions appropriately.
• External influence is highly desirable.

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.

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.