Fellow Late Phase Downstream Process Development
||Fellow Late Phase Downstream Process Development
||Lead and manage all project/network activities and apply scientific/technical expertise to address complex R&D issues for the preparation and timely delivery of drug substances (DS), processes and procedures; coach team members, participate in teams and contribute to overall strategies and goals.
Actively participate in teams, projects, networks /platforms.
Fulfill all related tasks and responsibilities related to own discipline including late phase DSP process development, process transfer to large scale, process characterization and process validation. Support manufacturing campaigns as subject matter expert scientifically and as needed for quality or safety.
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
Design, plan, perform and monitor all assigned activities.
Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms.
Support and assign associates in specific projects and/or networks. Coach on target dates and priorities.
Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects and/or networks.
Advise team members and work according to appropriate SOPís, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines.
Interpret results, evaluate data, draw relevant conclusions and write reports.
Contribute to optimization of scientific/technical activities in assigned projects, network and/or platforms. Contribute to optimization of processes within the own area of responsibilities.
Contribute to risk analyses and/or peer review and process challenge meetings.
Generate and select most appropriate scientific documents to hand over to internal and/or external partners (TechOps, authorities, other companies). (I)
Proactively support generation of international registration documents. Interact with authorities where appropriate.
Interact/collaborate with Research and/or other functions in Development to fa-cilitate transfer of knowledge and deliveries of DS.
Give support as a technical expert on audits and inspections.
Give support as a technical expert on Due diligence teams. Provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate.
Proactively contribute to setting, updating and monitoring of team goals. Translate team goals into daily work.
Support and facilitate the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Drive cultural evolution and change management. Support a culture of exceptional performance and continuous improvement, enabling innovative, competitive, compliant and consistent delivery on objectives of teams, projects, networks and/or platforms.
Inspire/coach/lead team members: support objectives setting, performance evaluations, development planning discussions and ensure all related tasks (objectives entered, help to identify needs for training courses and development of new skills, etc.) are performed appropriately. Participate in recruiting process.
Ensure all own activities are aligned with overall drug development process.
Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines.
Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives
||downstream, pufication, drug substance
Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent)
Good knowledge of English (oral and written).
Desirable knowledge of site language.
1. Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as principal scientist or equivalent.
2. Recognized expertise in a specific area.
3. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs.
4. Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications.
5. Thorough understanding of development processes in a specific function.
6. Profound literature search skills.
7. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
8. Proven leadership skills.
9. Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
10. Strong communication skills.
11.Strong presentation skills and scientific/technical writing skills.
12.Advanced coaching skills.
May require up to 15% travel
||Drug substance, Downstream process development, Purification
||Novartis Job ID: 195356BR.
||Nov 01, 2016 11:15:54
|Job last modified
||Nov 01, 2016 19:22:21