Manager, External Development

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How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.Position Description:·Initiates and manages the development of OTC drug products for Novartis Consumer Health OTC Business Unit for global projects using external resources. This includes, but is not limited to, managing the development of formulas, scale-up, manufacturing processes, process validation, analytical methods development/validation, stability testing, preliminary stability evaluation and manufacture and packaging of clinical supplies.·Assures products developed comply with general NCH quality policies and maintains proper compliance with GMP's, GLP's and SOP's by setting expectations at the contractor and holding them accountable.·Manages trimelines and the development cost for assigned projects while maintaining the quality of the development process and the finished product.·Assures the smooth transfer of manufacturing processes and analytical methods to Manufacturing Technical Services & Product Supply groups.·Supports Product Supply by assisting contractors with quality issues, scale-up, validation issues, process improvements and COGs reduction.·Works closely with Marketing in developing new product concepts and identifying a source to develop & manufacture these new products.Key Responsibilities:·Proactively manages the initiation, development, manufacture and overall timing of all assigned external projects and acts as core team member on assigned Project Teams. ·Monitors the manufacture and packaging of stability/clinical batches and validation batches.·Identifies and performs technical audits on potential external contract providers in the following areas: technology, analytical, formulation and clinical supply packaging and shipment.·Reviews and approves process validation protocols and reports.·Negotiates development agreements including costs, in concert with Purchasing, on assigned projects.·Writes or reviews Chemistry, Manufacturing and Controls or Module 3 sections and Expert Reports of NDAs, EU dossiers and Common Technical Documents.·Assists Project Management in planning of new projects by estimating resource and time requirements for technical development. Defines the technical activities.·Identifies best partners for outsourcing technical development.·Collaborates with Quality Unit to ensure the compliance of outsourced activities with cGMPs and Novartis Quality Manual.·Collaborates with Lincoln, Nyon & Thane Pharmaceutical Research & Development groups and project managers.·Provides technical support to Product Supply.·Ensures the quality of the technical documentation for global registration of outsourced projects.·Collaborates with OTC R&D functional unitsQualificationsPosition Requirements & EducationMinimum:·B.S. in Pharmacy or related Science and 15+ years relevant experience in the pharmaceutical industry or equivalent combination of education and experience with 4 to 6 years in a management position.·M.S. in Pharmacy or related Science and 10+ year's relevant experience in the pharmaceutical industry or equivalent combination of education and experience with 4 to 6 years in a management position.·Ph.D. in Pharmacy or related Science and 5+ year's relevant experience in the pharmaceutical industry or equivalent combination of education and experience.Experience/skills:·Experience in Pharmaceutical, OTC, Cosmetic, Dietary Supplements and Food formulation and process development, with knowledge of analytical development and validation.·Understanding of global development requirement and issues. ·Scientific & business understanding of ethical/OTC pharmaceuticals·Ability to work in an international and multidisciplinary environment·Negotiating skills·Project and people management skills·Good communication and presentation skills
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