Biopharmaceutical Process Lead
4 days ago
As a Biopharmaceutical Process Lead, you will be responsible for leading our GMP cell therapy manufacturing process. You will develop a comprehensive understanding of the process and ensure its execution with precision. This includes identifying training needs, establishing a feedback loop for continuous improvement, and maintaining accurate training documentation.
About the Role:The Biopharmaceutical Process Lead will work closely with the team to identify areas for improvement and implement changes to ensure the highest quality products. You will also be responsible for performing document review, including executed Batch Records and Logbooks, and supporting documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
Key Responsibilities:- Develop and execute a comprehensive understanding of the GMP cell therapy manufacturing process.
- Identify training needs and establish a feedback loop for continuous improvement.
- Maintain accurate training documentation.
- Ensure compliance with quality standards and requirements.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- 3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulation.
- Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
$120,000 - $150,000 per year, depending on location and experience.
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