Job Details
R&D Junior Sterile Manufacturing Scientist (Temporary Position)
Site Name: Italy - Parma
Posted Date: Mar 13 2023
R&D Junior Sterile Manufacturing Scientist (Temporary Position)
For the department R&D Clinical Supply Chain Sterile Operations in Parma we are looking for a Scientist to support clinical manufacturing business growth at Global Supply Chain Parma.
The new team member will work on projects in cooperation with GSC Parma and R&D Project teams and will be responsible for:
- Coordinate and supervise manufacturing activities of development and clinical lots at Parma Pilot Plant and Third-Party Contractors.
- Transfer product and process information from R&D development teams to Parma Pilot Plant, evaluating manufacturing feasibility through impact assessment and coordinating work of Parma supporting functions through SAP PL notification management.
- Support technology implementation to fill any gap identified during the impact assessment.
- Coordinate issue of key documents supporting drug products manufacturing (TTS, Manufacturing Guide, MBR...).
- Coordinate receipt for R&D of ingredients for drug products manufacturing and ensure smooth approval by Parma Quality Assurance.
- Ensure any process deviation is resolved and properly shared with R&D and provide appropriate documentation supporting clinical release to R&D QA.
- Coordinate drug product samples and clinical vials to the agreed destination.
- Support NPI clinical manufacturing at Parma commercial facilities.
The role, thanks to a variety of tasks, ensures knowledge acquisition on multiple R&D functions (Product Development, QA, Supply Chain...) and interactions with several GSK Parma units (Manufacturing Operations, QA, Regulatory, Validation, Micro and Chemical Labs, Import Export and Warehouse...).
Qualifications & Skills:
- Master's degree in Engineering (Chemical Engineering preferred)
- Good written and spoken knowledge of Italian and English.
- Good attitudes to team working and interactions with international stakeholders.
Preferred Qualifications & Skills:
- Basic knowledge of aseptically filled drug products manufacturing process and related GMPs.
- Excel advanced user.
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