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SOFIE manufactures radiopharmaceuticals and operates a contract manufacturing network serving diagnostic and therapeutic applications. The hiring profile is heavily skewed toward junior operations and manufacturing roles, with active recruitment accelerating across 46 open positions—typical for a production-scale operation managing multi-site compliance and equipment validation. Pain points cluster around manufacturing infrastructure (equipment downtime, calibration gaps, method validation) and regulatory harmonization across sites, suggesting SOFIE is scaling production capacity while tightening QMS and supplier controls under 21 CFR Part 211/212.
Tech Stack 13 technologies
Core StackSalesforce SAP ADP Microsoft Office SQL LIMS GCP HPLC Word Excel PowerPoint Microsoft Access Outlook
What SOFIE Is Building
◆Challenges
- Equipment downtime
- Gaps in calibration program
- Method validation complexity
- Equipment qualification maintenance
- Ensuring compliance with 21 cfr part 211 and 212
- Implementing qms across network
- Ensuring supplier quality compliance across multiple regulatory frameworks
- Harmonizing supplier qualification across sites
- Maintaining consistent supplier quality processes
- Validating production methods
▲Active Projects
- Development of manufacturing methods for new radiopharmaceuticals
- Calibration master plan update
- Commissioning and qualification of new equipment
- Validation of analytical methods for new radiopharmaceuticals
- Implementation of production protocols for clinical-grade radiopharmaceuticals
- New radiopharmaceutical process implementation
- Radiological checks of equipment
- New site rollouts
- Api integrations
- Custom reporting solutions
Hiring Activity
45 roles · 30 in 30d
Department
Seniority
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