Duration: 6+ Months with extensions
Start Date: ASAP
Our biotech client is a Scientist or Senior Research Associate to facilitate with the development of cell therapy products. The resource will work closely with CDMOs for analytical tests development using QbD and DoE approaches, while also collaborating with R&D/QC teams to advance the company’s pipeline programs.
Develop and optimize analytical tests with CDMOs and CROs.
Apply cell biology principles and technical aptitude for analytical methods.
Evaluate and define analytical approaches to meet regulatory guidelines.
Analyze data, write technical reports, and make suggestions based on results.
Drive design and analysis of analytical tests, applying innovative techniques.
Provide support for deviation investigations and method development.
Expertise with aseptic tissue culture techniques – required
BS with 8+ years, MS with 6+ years, or PhD with 0-3 years of relevant industry experience.
Motivated, self-start who works well in team environments.
Detail-oriented, highly organized, and eager to learn new skills.
Proficiency in aseptic tissue culture techniques.
Working knowledge of molecular and cell biology analytical methods.
Excellent communication and planning skills.
BONUS/Nice to have:
Experience with cell therapy and GLP/GMP.
Knowledge of automated methods for cell analysis.
Experience with assay qualification/validation for cell therapy products.
Familiarity with GMP, ICH, USP, JP, EU, and global compendial regulations and guidance.
Scientist/Research Associate (233590) Cambridge, MA