Scientist - Technical Development

Job Description Summary

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy.

Job Description

Major Accountabilities:

• Independently plan, organize, perform and document scientific experiments /GMP testing /manufacturing plant activities under minimal supervision; handle several activities at a time -Take over responsibility for and utilize special tools /equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments / equipment -Proactively identify conflict situations and contribute to solutions -Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement -Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments.
• Review and verify raw data generated by others; approval of tests / experiments performed by others -Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision -For technical development units: Develop new methods or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies -For GMP units: ensure compliance to cGMP -For technology-focused roles: Perform information and literature searches under minimal guidance.
• Actively foster knowledge exchange.
• Train and coach associate scientists, technicians, temporary employees and employees under training / education -For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision -Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Establish innovative solutions for verification and control of critical quality attributes, critical material attributes or critical process parameter in cooperation with other colleagues.
• Establish control procedures and specifications and review test procedures.
• Generate scientific documents to hand over to internal and / or external partners (e.g., MST, TechOps, authorities, external companies ) and support generation of international registration documents under minimal supervision.
• If assigned this task, maintenance of infrastructure / equipment and required investments ( e.g. system ownership) -Generate lab procedures or SOP’s, generate protocols and reports -Lead technical meetings during product development at the local level as well as on the level of SDC network -Report and present scientific /technical results internally and contribute to publications, presentations and patents.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key performance indicators:

• Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

Minimum Requirements:

• Up to 10 years of relevant experience (M.Pharm./M.Sc.) or a Ph.D. in trace-level quantification of GTIs, nitrosamines, and nitrites in drug substance (DS) and drug product (DP).

  
  
  

• Hands-on experience with nitrosamine analysis, including NDSRIs; prior experience in this area is strongly preferred.

  
  
  

• Strong expertise in qualitative and quantitative analysis using LC-MS, HRMS, and other mass spectrometry-based analytical techniques.

  
  
  

• Sound understanding of nitrosamine-related regulations and guidelines, with the ability to independently design study protocols and plan experiments.

  
  
  

Skills Desired

Materials Science, Process Simulation, Technical Writing, Waterfall Model