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. Manage technical lab/plant activities. -Management TrackLead a team for the development of pharmaceutical / biological / cell-gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. -SANDOZ: -Associate Scientist: Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery of drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Scientist: -Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery 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 SZ strategies and goals -Senior Scientist: Design, plan, perform -document and interpret scientific/developmental experiments and GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.
About the Role
Major accountabilities:
- Meet quality, quantity and timelines in all assigned projects. Ensure all own activities are aligned with overall drug development process.
- Plan, organize, perform and document scientific experiments/plant activities in collaboration with project teams and under minimal guidance from more experienced team members (eg. contribute to interpretation and report results). Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
- Provide efficient and robust processes for the manufacture and/or specialized facilities e. g. containment/sterile labs as an expert w/ adequate guidance.
- Provide raw data documentation, evaluation and results interpretation. Propose and provide input for the design of next experiments.
- Optimize existing methods, procedures, workflows (lab or plant) and develop more efficient ones.
- Generate lab procedures, reports and/or instructions and/or SOP s.
- Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls etc
- Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team member.
- Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility.
- Collaborate with other team members to facilitate deliveries of DS and/or DP.
- Utilize special tools/equipment and/or specialized facilities e. g. , containment/sterile labs.
- Evaluate new lab equipment.
- Contribute to maintenance of infrastructure/equipment.
- Ensure all own activities are aligned with overall drug development process.
- Support team s resource planning and effective resource utilization
- Support and foster strong quality/compliance mindset for own projects and overall portfolio/initiatives. Ensure internal processes as per SOPs/guidelines are followed and internal quality metrics are met. Fully support GxP and general deliverables.
- Ensure training is up-to-date and on time; no overdue training assignments without acceptable cause.
- Ensure strict adherence to HSE rules and guidelines.
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:
- B. Pharm /M. Pharm with relevant experience of around 3-8 years.
- Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment.
- Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
- Thorough knowledge of relevant SOP, GMP regulations and policies if applicable.
- Adequate knowledge in scientific/technical areas of collaboration.
- Proficient with laboratory and/or technical tools.
- Adequate knowledge of software and computer tools.
- Basic presentation skills and scientific/technical writing skills.
- Good Communication skills
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