Analytical Development, Gene Therapy

Our client is a Series B gene therapy start-up in the suburbs of Boston/Cambridge with proprietary AAV IP born out of Harvard Medical.  They are well-funded and growing!
The main function of this role is to develop fit-for purpose molecular and cellular bioassays to support non-GMP characterization of research and process development material.
Responsibilities include but are not limited to;
•  Development and qualification of ddPCR/qPCR-, ELISA-, and cell-based bioassays (TCID50, in vitro potency, and neutralizing antibody) and subsequent analysis of in process and drug substance samples
•   Assay qualification and/or validation activities for selected analytical methods according to appropriate guidelines (GMP, ICH)
•  Assist with the transfer of qualified assay methods internally to cross-functional teams and eventually to CRO/CDMO partners
•  Author and review SOPs, test methods and other controlled documents in the validated QMS document management system
•  Mentor and/or train junior team members in the analytical development lab
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS/MS/PhD with 2-6+ years of relevant industry experience with analytical methods associated with gene therapy drug product characterization (titer, purity, contaminants, potency) and common statistical analysis methods and software related to method development and validation.  
Must be commutable to Greater Boston (Waltham/Watertown 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.