US-TX, Senior Fellow - Formulations Project Lead 220603BR-MZ
Senior Fellow - Formulations Project 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 formulation development and issues. Actively support TRD strategies and goals by participating in cross-functional teams. Lead formulation development and advancement in scientific programs; co-ordinate interdisciplinary projects and teams. Develop long term strategies on formulation science and technologies.
Basic Major Activities (Describe main 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 con-clusions. Lead risk analyses and/or peer review and process challenge meetings. In-teract/collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and deliveries high quality and innovative sterile liquid formu-lations. Actively 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. Provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate
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 project team member(s). Develop, monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken. Permanent measurement, benchmarking, and continuous improvement of KPI for the unit. Proactively contribute to setting, updating and monitoring of team goals.
4. Translate team goals into daily work; and support and assign associates in projects and networks. Coach function associates on target dates and priorities. Act as a role model and energize the team. 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. 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.
Inspire/coach/lead team members: support objectives setting, performance evalua-tions, and 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. Actively participate in recruiting process. Develop, mentor and coach other team members within and/or across the PHAD/TRD-PTO. Act as a mentor, coach and trusted go-to person for associates, helping them grow to their potential. 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 plat-forms. Advise team members and work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines. Provide quality documentation and as-sessments in a timely manner and support follow-up activities as appropriate.
6. Optimize scientific/technical related activities in assigned projects, networks and/or platforms. Create and implement optimized processes and procedures for activities within the own area of responsibilities. Identify need and opportunity for outsourcing. Provide input to contracts and QA-agreements with 3rd parties and lead outsourced tasks/projects with 3rd parties as appropriate. Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects and/or networks. Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
S&T Specific Activities
1. Initiate and lead new scientific/development programs. Evaluate and implement new scientific technologies.
2. Provide scientific/technical leadership for efficient and robust processes for the manufacture and/or analysis of intermediates, drug substances and drug products as per own discipline.
3. Report and present scientific/technical work at internal/external meetings/ conferences and publish in peer reviewed international scientific journals including pa-tents.
4. Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.
5. Oversee maintenance of infrastructure/equipment and required investments.
Key Performance Indicators
1. Accountability for 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. Outcome of risk analyses, process challenge meetings, audits and inspections.
6. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
7. 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.
Formulation Sciences Ph.D. or equivalent.
Good knowledge of English (oral and written). Desirable knowledge of site language.
8+ years of formulation and/or process development experience in the Pharmaceutical industry developing solutions and leading formulations or drug product process development programs. Recognized expertise in formulations and/or process development.
Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as fellow or equivalent.
Recognized expertise in a specific area and broader scientific as well as strategic background.
Proven track record of creativity, problem solving and productivity in projects.
Good overview of current trends and upcoming techniques for current and future applications.
Thorough understanding of development processes in TRD.
Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
Excellent leadership skills.
Thorough knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
Excellent communication/presentation skills and scientific/technical writing skills. Advanced coaching and mentoring skills.
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