Roche
Pharma
TechnicalDevelopmentLeader(TDL)LargeMolecules
Neural analysis suggests this role is
optimal for Senior candidates.
“Technical Development Leader (TDL) Large Molecules at Roche. Skills: Technical Development Teams (TDTs) leadership, Chemistry, Manufacturing, and Control (CMC) strategies development, Product lifecycle management, Manufacturing processes design, Drug product configurations, Device configurations, Global supply chains design, Risk mitigation, Contingency plan development. Lead Technical Development Teams (TDTs) to develop and drive Chemistry, Manufacturing, and Control (CMC) strategies for clinic”
What You'll Achieve.
Ensure seamless regulatory approval and commercial success; Ensure flawless execution
Industry & Context.
Critical Thinking; Risk mitigation; Contingency plan development
What They're Looking For.
Must Have
Extensive pharmaceutical industry experience, Background in biologics process development, CMC team leadership, Advanced understanding of the full drug development process, Demonstrated ability to handle complex cross-functional programs, Thinking strategically, Thinking proactively, Exceptional negotiation skills, Exceptional verbal/written communication skills, Track record of influencing senior management and third parties
Nice to Have
Business acumen
What You'll Do.
Lead Technical Development Teams (TDTs) to develop and drive Chemistry
and Control (CMC) strategies for clinical drug candidates from early human trials through product launch
Ensure technical integrity and proactive risk mitigation
Lead technical teams throughout the product lifecycle
from preclinical development to product launch
Ensure the scientific integrity of the CMC strategy
Design and implement multifaceted technical strategies - encompassing manufacturing processes
drug product and device configurations
and global supply chains - to ensure seamless regulatory approval and commercial success
Provide enterprise-level perspectives to ensure deliverables remain patient- and customer-focused
Serve as a primary liaison to asset teams
senior management and governance committees
Deliver transparent updates that facilitate informed decision-making
Oversee end-to-end CMC development
including financial stewardship
and milestone tracking to ensure flawless execution
Drive informed decision-making for CMC investments and risk mitigation
Develop robust contingency plans and proactively communicate potential impacts to relevant leadership and governance bodies
How You'll Work.
Team & Collaboration
Lead technical teams throughout the product lifecycle; Serve as a primary liaison to asset teams, senior management and governance committees; Proactively communicate potential impacts to relevant leadership and governance bodies
Communication Scope
Exceptional negotiation skills; Exceptional verbal/written communication skills; Track record of influencing senior management and third parties; Transparent updates delivery; Proactively communicate potential impacts
Process & Methodology
Program Management, Handle complex cross-functional programs, Milestone tracking
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position 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 As a TDL, you will lead Technical Development Teams (TDTs) to develop and drive Chemistry, Manufacturing, and Control (CMC) strategies for clinical drug candidates from early human trials through product launch ensuring technical integrity and proactive risk mitigation. * Leadership: Lead technical teams throughout the product lifecycle, from preclinical development to product launch, ensuring the scientific integrity of the CMC strategy. * Strategy & Execution: Designs and implements multifaceted technical strategies - encompassing manufacturing processes, drug product and device configurations, and global supply chains - to ensure seamless regulatory approval and commercial success. * Enterprise Alignment & Governance: Provides enterprise-level perspectives to ensure deliverables remain patient- and customer
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