Group Head Late Phase Bio-Pharmaceutical Development
Inseriert am: 07.02.2018
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Apply to JobJob ID223492BRPosition TitleGroup Head Late Phase Bio-Pharmaceutical DevelopmentJob DescriptionGroup Head Late Phase Bio-Pharmaceutical Development
Lead a late phase pharmaceutical development team of scientists and technicians as direct reports. Provide oversight, senior expertise and guidance to product and technology projects driven by drug product leaders in team. Review and/or approve technical/regulatory documents as responsible line function. Ensure optimal project support by proactive management of team resources and infrastructure. Contribute to strategic setup of expertise, equipment and technology within DPD.
Develop talents of team members by definition of individual development plans and ensure execution as well as regular follow-ups. Mentor and coach scientific associates in team and actively drive knowledge exchange within DPD unit. Perform the annual performance review cycle with all team associates. Define talent needs in-line with DPD strategy and develop them accordingly or support in acquisition from internal or external sources. Maintain interfaces to local and global pharmaceutical development units, commercial manufacturing sites, external supply operations, analytics and regulatory. Support alignment / harmonization of development strategies and definition of responsibilities in network and with partner organizations; optimize use of resources and throughput times in interfaces. Provide mentoring, coaching and knowledge exchange to global DPD partner organizations. Ensure own and team work is executed according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement; advise team members and ensure all own and team activities are aligned with overall drug development process. With approximately 50% of capacity lead and manage own project/network activities in drug product development of late phase Biologics and apply scientific/technical/quality-related expertise to address complex R&D issues within multifunctional teams. Lead drug product sub-teams; represent own function in technical teams (e.g. global CMC team) and fulfill all project tasks and responsibilities related to the own discipline. Assess and consolidate resource needs and timelines for project(s), network(s) and/or platform. Communicate effectively across organizational interfaces; lead the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training Write impactful and wide-reaching process-related development guidelines and drive their implementation; write excellent scientific reports intended for external partners and support generation of registration documents; interact with authorities where appropriate; act as technical expert in audits, inspections or due diligences.Minimum requirementsPhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge. Excellent English required (oral & written); good skills in German as site (local) language desired (oral) At least 10 years relevant experience in pharmaceutical industry, thorough understanding of late phase pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background Thorough track record of process transfer, validation and regulatory submissions including health authority inspections. - In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage.
- Pronounced talent for and proven experience in people management is essential.
- Excellent skills in scientific project management, leadership and presentation to senior management Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projectsDivisionNovartis Technical OperationsBusiness UnitNTO BTDMLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
