Clinical Supplies Operator

Job description

Job Description

Job Purpose (State in one sentence the overall objective of the role)
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..
Basic Major Activities
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. Actively participates in project teams/meetings/networks and contributes to team goals.
12. Proactively contribute requested cost information for projects/networks.
13. Work according to appropriate SOP’s, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines.
14. Evaluate data, draw relevant conclusions and write reports.
15. Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regula-tions.
16. Interact/collaborate with other functions in Development to facilitate transfer of knowledge and deliverables with the production of clinical supplies.
17. 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.
18. 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 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.

Posting Title

Clinical Supplies Operator

Desired profile

Minimum requirements

Education :
•Minimum: Technician with continuing education (EU) or BS/MS or equivalent
•Desirable: MS or equivalent

Experience
•Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as scientist or 3-5 years (for BS) or 1-3 years (for MS).
•Knowledge of cGMP and Annex 13 requirements
•Strong scientific and technical knowledge skills: in product manufacturing, sterile garbing, warehousing / logistics and inventory management.
•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
Job Type

Full Time
Country

USA
Work Location

Fort Worth, TX
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

TECHNICAL R & D GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.