Summary Design, plan and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. Management Track -Lead a team for the development of pharmaceutical working in a multidisciplinary environment. Execute and support developing the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, NTO and NIBR plans. and objectives; apply scientific/technical/ GMP and/or quality-related expertise to address complex R &D issues; develop strategies based on science and technologies.
Major accountabilities:
Oversee and lead all activities of assigned teams /projects; meet customer needs.
Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security; lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures.
Evaluate and interpret results, draw relevant conclusions; supervise project related activities; perform complex tasks without having established procedures.
Oversess and may also write protocols, scientific reports, lab procedures or process.
related SOPs; write scientific documents intended for external partners or for generation of registration documents; interact with authorities -Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
For technical development units: Develop complex methods (lab or plant); lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s); guide development and implementation of new technologies.
For GMP units: ensure compliance to cGMP.
For technology focused role: Provide scientific and technical guidance; actively foster knowledge exchange.
Develop, mentor and coach other scientific associates; present scientific /technical results internally and contribute to publications, presentations and patents.
For project-focused role: Lead assigned teams; represent own technical function in teams and fulfill all project tasks and responsibilities related to the own discipline -Broadly uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways -Contributes to many cost center goals and objectives; may contribute to service line goals .
Develop detailed plans and timelines and plans for projects from development to cGMP manufacture.
Ensure accurate, speedy reports are produced
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Key performance indicators:
Adherence to costs, quality, quantity, and timelines for all assigned tasks.
Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
Feedback from other team leaders and advisory boards.
Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented.
Refer to annual individual and team objective setting.
Internal and external publications/presentations, invited lectures.
Successful and effective execution of assigned tasks within given timelines at expected quality; right the first time and on time; demonstrate initiative and strive for high level of quality.
Measurable contributions to efficiency increase and productivity.
Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented.
Minimum Requirements:
Work Experience:
People Challenges.
Managing Crises.
Functional Breadth.
Project Management.
Operations Management and Execution.
Collaborating across boundaries.
Skills:
Coaching Skills.
Data Science.
Environment.
Experiments Design.
Health And Safety (Ehs).
Laboratory Equipment.
Manufacturing Process.
Materials Science.
Process Simulation.
Project Management.
Sop (Standard Operating Procedure).
Technical Writing.
Languages :
English.
Skills Desired Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model
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