Job Purpose (State briefly the overall objective of the job)
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.
Basic Major Activities (Describe main activities)
1. Meet quality, quantity and timelines in all assigned projects.
2. Design, plan and perform scientific experiments/plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team member (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, write reports).
3. Provide scientific and technical guidance. Coach team members as needed.
4. Provide efficient and robust processes for the manufacture and/or analysis of intermediates, DS and DP under adequate guidance from more experienced team members.
5. Generate scientific documents to hand over to internal and/or external partners (e.g., TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
6. Contribute to risk analyses and/or peer review and process challenge meetings.
7. Interact/collaborate with other groups/functions to facilitate transfer of knowledge and deliveries of DS and/or DP.
8. Give guidance to team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and The company guidelines.
9. Utilize special tools/equipment and/or specialized facilities e.g., containment/sterile labs as an expert.
10. Evaluate new lab equipment and prepare CAR and USR if applicable.
11. Report and present scientific/technical results internally and contribute to publications, presentations and patents.
12. Contribute to maintenance of infrastructure/equipment.
13. Actively contributes to team goals.
Key Performance Indicators (Indicate how performance for this job is measured)
1. Adherence to costs, quality, quantity, and timelines for all assigned tasks.
2. Adherence to The company 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.