Director, Cell Therapy Bioanalysis

Our Cambridge-based cell therapy client was founded in 2020, quickly built a team of nearly 100 people, and recently secured over $100 million in funding! With nearly $200 million since their founding, this oncology start-up is well positioned for growth and successfully bringing innovative cell therapies to oncology patients.  

The main function of this role is to build and lead a team of scientists to develop bioanalytical plans and be involved in the design, development, qualification, and validation of quantitative assays supporting cell therapy research and development.

Responsibilities include but are not limited to;
•  Serve as SME on development, qualification, and validation of relevant assays; protein (LC-MS, ELISA), molecular (qPCR, ddPCR), and cellular (flow cytometry, ELISpot) 
•  Identify CROs, oversee method development, transfer, and method validation at select partners
•  Review and approve method qualification/validation reports and sample analysis reports
•  Ensure adequate and timely bioanalytical support of non-GLP and GLP preclinical and clinical studies
•  Develop internal guidelines for bioanalytical method development and ruggedness evaluation in support of preclinical studies
•  Ensure project compliance with external regulatory requirements and internal guidelines
•  Drive innovation and implementation of new experimental strategies within group via new technologies and instrumentation

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a MS degree or higher in a relevant life sciences discipline (cell biology and immunology preferred) and 10+ years’ experience in the development of assays to support cell therapy, gene therapy, and/or biologics.  Must have extensive experience in protein assays, molecular techniques, and cellular assays in conjuction with knowledge of current regulatory guidance and industry best practices in cell and gene therapy bioanalysis.  
Also seeking demonstrated leadership experience in both project and people management as well as familiarity with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.

Must be authorized to work in the US to be considered and be commutable to the Cambridge area or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.