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Upstream Pharmaceutical Production Specialist
2 weeks ago
Social networks can help you find work:
Upstream Specialist RoleWe are looking for an expert to join our team in Dublin.
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Client:A pharmaceutical organization is seeking a highly skilled professional.
Location:Dublin, Ireland
Job Category:Technical Services
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EU work permit required:Yes
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Responsibilities:
- Cell culture processes including media preparation, large-scale manufacturing and bulk drug substance production.
- Authoring and reviewing technical documents, strategy and process validation reports.
- Liaising with colleagues to oversee laboratory studies and execute study designs.
- Introducing new materials and consumables through material lists, Bills of Materials and testing requirements.
- Collaborating with Quality, Supply Chain and Manufacturing Operations teams.
- Implementing process improvements and ensuring cGMP compliance.
Required skills and experience:
- 5+ years' experience in Technical Services or Process Development within a biological manufacturing organization.
- Operational knowledge of unit operations in cell culture processing.
- cGMP requirements for biopharmaceutical manufacturing.
- Experience with Technology Transfer activities is advantageous.
Key qualifications include:
- Bachelor's degree in a related field.
- Strong understanding of cell culture processing and cGMP regulations.
- Excellent communication and problem-solving skills.
- Ability to work collaboratively and lead projects.
