Roche is leading the industry with respect to the investment in R&D. We drive one of the largest and most promising pipelines. Pharma Technical Development (PTD) engages with all R&D engines within the Roche group and supports more than 100 development projects with CMC (Chemistry, Manufacturing and Controls) activities.
In the role of Technical Development Leader (TDL) you will lead cross-functional Technical Development Teams (TDTs) in developing and implementing Chemistry, Manufacturing & Control (CMC) strategies and activities throughout a product's lifecycle to deliver novel gene therapies to our patients.
You are the primary advocate for development programs on CMC strategies, activities and issues and are accountable for ensuring that the TDT is successful in achieving predefined goals and delivering upon the Integrated Project Plan. You represent CMC functions with stakeholders, on Research Project Teams, Life Cycle Teams and when interacting with external partners.
Your contribution is key to ensure adequate information flow between team members, to functional management, and to governance committees to ensure transparency and efficient alignment of all technical deliverables with the Project Team strategy and Clinical Development plan.
In this purposeful role on the edge of our innovative products you will:
Lead technical development teams in developing and implementing CMC strategies and activities associated with gene therapy programs from pre-EIH, during preparation of major regulatory filings throughout approval and launch in major countries
Establish a close and trustful collaboration with your team members, technical functions and key stakeholders within the Research, Development and Technical Operations organizations globally as well as with external partners
Ensure the scientific integrity of the technical development process, CMC strategy, and TDT deliverables (manufacturing processes, control systems, drug product formulations & configurations, risk management plans, regulatory submissions and clinical/launch supplies) and partner with Project/Lifecycle Team Leaders and associated team members to develop and deliver the integrated product development strategy
Ensure the TDT is successful in making progress toward its goals and adheres to timelines, milestones, and resource forecasts as previously defined and in agreement with license partners
Establish effective decision-making processes, enabling decision-making at the lowest appropriate level on the team and encourage informed risk taking and minimum viable development strategies
Identify and lead continuous improvement activities, including implementation of new technologies into your projects as well as contributing to the development of department business initiatives on new ways of working
Education and Professional Background
Masters or Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
Several years (at least 8 years) of experience in the pharmaceutical industry ideally with prior experience as a CMC team leader, combined with a strong technical knowledge and special expertise in gene therapies
Experience of working with third parties is an advantage
Proven track record of technical accomplishments in the gene therapy field
Ability to build and lead cross-functional matrix teams providing clear prioritization of project goals and enabling collaborative decision making in the team
Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross-functional areas.
Ability to simply and clearly articulate deliverables to technical and non-technical audience across the organization
Strong interest to embrace new ways of working and to act as change agent
Proven ability to work proactively and think strategically, including assessment of business impact of technical decisions
Proven ability to work with senior management and to effectively partner and influence stakeholders and partners
Roche is an equal opportunity employer.Research & Development, Research & Development > Research