Scientist I, Analytical & Quality Control
$113,464–$140,000 year
Hybrid · Cambridge, Massachusetts, United States
Job Summary
Scientist I, Analytical & Quality Control supports analytical studies for BlueRock programs, designs and plans experiments, coordinates with internal/external partners, analyzes data, and documents results. The role involves developing and implementing analytical methods and technologies to improve understanding of therapeutic cell product candidates, ensuring assay requirements for characterization, lot release, and comparability, performing various cellular/molecular assays, tracking data, documenting results in ELNs, authoring SOPs and study protocols, and ensuring regulatory compliance across regions. The position isHybrid (office 3 days/week) located in Cambridge, MA, with a salary range of $113,464 to $140,000." ,
Required Qualifications
- PhD or equivalent in Biological Sciences or related field plus 1 year of relevant experience; or Master’s degree or equivalent plus 4 years
- Experience in Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing
- Extensive experience with cell characterization methods and analytical technologies (imaging, cell-based assays, qPCR, qPCR/ddPCR, RNAseq, functional assays, mammalian cell culture)
- Experience with Good Documentation Practices and working in a cGMP or equivalent environment
- Experience in qualification, validation, transfer, and life cycle management of analytical methods
- Experience with writing technical reports and regulatory documents presenting data clearly and concisely
- Excellent organizational and problem-solving skills, with ability to work cross-functionally
- Excellent written and oral communication skills; strong organizational skills and attention to detail
- Competency with Microsoft Office (Word, Excel, PowerPoint)
Desired Qualifications
- PhD or equivalent in Biological Sciences or related field
- Experience in Biotechnology, cell therapy, pluripotent stem cells, gene editing
- Experience with cell characterization methods and analytical technologies (imaging, cell-based assays, qPCR, qPCR/ddPCR, RNAseq, functional assays, mammalian cell culture)
- Experience with Good Documentation Practices and cGMP or equivalent environment
- Experience in qualification, validation, transfer, and life cycle management of analytical methods
- Experience with writing technical reports and regulatory documents presenting data clearly
- Excellent organizational and problem-solving skills
- Proficiency with Microsoft Office suite
- Ability to work in a hybrid office environment and collaborate cross-functionally
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