Clinical Supplies Operator, Associate Scientist job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
Under daily supervision, supports the aseptic set up, manufacture (compounding, fill) and finishing (label, bulk shipment) of sterile clinical products according to cGMP re-quirements.|
1.Demonstrate a good working knowledge of the GMP requirements associated with the cleaning, changeover, setup, startup, operation, breakdown and sampling of compounding areas and filling lines for sterile clinical products. 2.Demonstrate good aseptic technique and understanding of sterile garbing require-ments. 3.Demonstrate good documentation practices according the cGMP requirements for all records. . 4.Perform visual and physical inspections of in process and finished products as re-quested 5.Operate under the direct supervision/leadership of a Lead Operator and/or Super-visor 6.Assist in labeling, packaging and shipment of bulk finished goods to GCS 7.Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline. 8.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). 9.Plan, perform, monitor and report all operational activities. 10.Meet quality, quantity and timelines in all assigned projects, networks and/or plat-forms. 11.Proactively contribute requested cost information for projects/networks. 12.Work according to appropriate SOP's, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines. 13.Report data, and align with team and leaders to draw relevant conclusions and write reports. 14.Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regula-tions. 15.Interact/collaborate with other functions in Development to facilitate transfer of knowledge and deliverables with the production of clinical supplies. 16.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. 17.Monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken.
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.•Minimum: Technician or adequate education •Desirable: BS/MS or equivalent ENGLISH •Minimum of 3 years of experience as Technician (promotional pathway) or 0-4 years (for BS) or 0-2 years (for MS). Awareness for safe handling of chemicals, potentially dangerous materials and equipment. •Knowledge of cGMP and Annex 13 requirements •Strong scientific and technical knowledge skills: in product manufacturing, sterile garbing, warehous-ing / logistics and inventory management. •Prior experience in aseptic processing of liquid products in a GMP, audited facility •Proficient with equipment and/or instruments. •Demonstrating leadership behaviors through posi-tive words and actions. •Adequate knowledge of software and computer tools. •Basic presentation skills and scientific/technical writing skills •Good communication skills