Team Supply Associate Scientist

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Job description

Job Description

Role Profile: Scientist, Clinical Supply Team General (organization chart to be attached) Job Title:
Department:
Reports to (Job Title): Clinical Supplies Operator
Clinical Supply
Team Lead Technical/Leadership : Technical 100% Job Purpose (State in one sentence the overall objective of the role) Under daily supervision, supports the aseptic set up, sanitization, manufacture (compounding, fill) and finishing (label, bulk shipment) of sterile clinical products according to cGMP requirements. Basic Major Activities

1. Demonstrate a good working knowledge of the GMP requirements associated with the cleaning, changeover, setup, startup, operation, breakdown, sanitization and sampling of compounding areas and filling lines for sterile clinical products.
2. Demonstrate good aseptic technique and understanding of sterile garbing requirements.
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 requested
5. Operate under the direct supervision/leadership of a Lead Operator and/or Supervisor
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 platforms.
11. Proactively contribute requested cost information for projects/networks.
12. Work according to appropriate SOP's, GLP, GMP, QM, QD, HSE, ISEC and Client 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 Client QM, QD and global regulations.
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.

Operational Development Specific Activities -

1. Plan, perform and contribute to project batch production by proactively considering potential issues associated with equipment, instruments, and processes to allow resolution prior to initiation.
2. Create and implement efficient and robust procedures/processes for the manufacture of clinical products
3. Plan, create and execute appropriate change control management according to SOP and QM requirements
4. Coordinate with team members to ensure all activities required to support batch are successfully completed to maintain scheduled batch activities
5. Proactively provide ideas to enhance efficiency and/or effectiveness of operations.
6. Report and present own work at internal meetings
7. Demonstrate compliant GDP in all GMP records
8. Support all, and lead multiple activities related to assigned projects

Key Performance Indicators (Indicate how performance for this job is measured)

1. Accountability for costs, quality, quantity, and timelines for all assigned tasks.
2. Adherence to Client 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.

Job Dimensions (Indicate key facts and figures) Number of associates: Direct reports: 0 Financial responsibility:
(Budget, Cost, Sales, etc.) Project and warehouse/logistics spending within budget. Impact on the organization: Actively contributes to Supply Team objectives by delivering quality clinical supplies according to established timelines with supporting GDP compliant documentation according to Client QM, SOP, global regulations. Background (State the required education, experience level, and competency profile) Education :

• Minimum: BS or equivalent
• Desirable: MS or equivalent

Languages: Good knowledge of English (oral and written).
Experience:

• Minimum 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, sanitization, warehousing / 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 positive words and actions.
• Adequate knowledge of software and computer tools.
• Basic presentation skills and scientific/technical writing skills
• Good communication skills

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