US-TX, Fellow - Formulations/Process Lead 220604BR-MZ
Fellow - Formulations/Process Lead
Global Drug Development
TECHNICAL R & D GDD
Fort Worth, TX
Research & 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 formulations, processes and procedures; coach team members, participate in teams/networks and contribute to overall GDD, TRD and PTO formulation science and process development strategies and goals.
Basic Major Activities
1. Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline and ensure all own activities are aligned with overall drug development process. Design, plan, perform and monitor all assigned activities; as well as interpret results, evaluate data, draw relevant conclusions. Contribute to risk analyses and/or peer review and process challenge meetings. Interact/collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and deliveries for drug products. Provide strategic and scientific contribution to Networks, with target achievements according to network charter and objectives.
2. Proactively support generation of international registration documents, including interaction with authorities where appropriate. Generate and select most appropriate scientific documents to hand over to internal and/or external agencies or partners. Actively support TRD as a technical expert on audits, inspections and Due Diligence teams as required.
3. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant pro-ject team member(s). Proactively contribute to setting, updating and monitoring of team goals.
4. Translate team goals into daily work; and support and assign associates in pro-jects and networks. Coach function associates on target dates and priorities. Support a culture of exceptional performance and continuous improvement, en-abling innovative, competitive, compliant and consistent delivery on objectives of teams, projects, networks and/or platforms. Support and facilitate the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Inspire/coach/lead team members by ensuring all related tasks (objectives entered, help to identify needs for training courses and development of new skills, etc.) are performed appropriately. Engage and drive culture change consistent with GDD values and objectives. Consistently lead good change management practices to protect product quality.
5. Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines. Provide quality documentation and assessments in a timely manner and support follow-up activities as appropriate.
6. Contribute to optimization of scientific/technical activities in assigned projects, network, platforms and processes within the own area of responsibilities. Proac-tively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects and/or networks.
S&T Specific Activities
1. Identify and drive implementation of new scientific technologies and approaches.
2. Provide efficient and robust processes for formulation and/or process development as per own discipline.
3. Report and present scientific/technical results internally and publish/present exter-nally in scientific journals and conferences including patents.
4. Ensure maintenance of infrastructure/equipment and required investments.
Key Performance Indicators
1. Adherence to costs, quality, quantity, and timelines for all assigned tasks.
2. Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
3. Feedback from other team members/leaders.
4. Refer to annual individual and team objective setting.
5. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
6. Internal and external publications/presentations, invited lectures.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: BS/MS in Formulation Sciences or applicable discipline.
Desirable: Advanced degree in applicable scientific discipline (Ph.D. or equivalent).
Good knowledge of English (oral and written). Desirable knowledge of site language.
1. 8+ years of packaging experience in the Pharmaceutical industry developing solutions and leading formulations or drug product process development programs. Recognized expertise in formulations and/or process development.
2. Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications.
3. Thorough understanding of development processes of formulation and/or process development.
4. Profound literature search skills.
5. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
6. Proven leadership skills.
7. Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
8. Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
9. Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as principal scientist or equivalent.
10. May require up to 15% travel.
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