Global Head, Biologics Analytical Development and Quality Control (ADQC)

at  Roche

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The Position

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 developmen

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 appropriat

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 desirabl