Scientist / Senior Scientist, Bioanalytical (DMPK)

SUMMARY: 

Generation Bio is seeking a highly motivated, energetic and enthusiastic scientist/sr. scientist to join our rapidly growing DMPK/bioanalytical team to support preclinical and early clinical development phases of non-viral vector-based gene therapies. We are seeking an exceptional individual to fill this critical role in our organization. The primary job responsibilities include LC-MS/MS based bioanalytical method development, sample analysis in various biological matrices, data analysis and reporting. The candidate is expected to work independently to develop LC-MS/MS assays for bioanalysis of lipid nanoparticle (LNP) formulations and efficiently execute sample analysis. This individual will create bioanalysis capacity in the department by training DMPK members and through the identification, development, and management of CRO relationships. This is a significant opportunity to build the required in-house capability and the candidate is expected to be an independent thinker, a self-starter, and someone who is skilled at working across functions. The job responsibilities include working closely with CRO’s to transfer assays, provide scientific oversight for externally sourced studies, as well as ensure seamless execution in collaboration with our Operations team. Significant cross functional interactions are expected with key partnership between Pharmacology, Toxicology, and other departments.

RESPONSIBILITIES:

• Design, optimize, and execute assays to assess drug concentration in in vitro and in vivo samples, in various biological matrices
• Build in-house LC-MS/MS bioanalytical capacity
• Employ cutting edge technologies to understand pharmacokinetics and biodistribution attributes of this exciting new modality
• Scientific oversight of CRO activities for outsourced studies including method transfer, data quality and analysis
• Design experiments, analyze data & interpret results
• Summarize studies in high quality written reports and oral presentations

QUALIFICATIONS:

• PhD degree in related field, or Masters degree with minimum of 8 years of related experience, or Bachelor’s degree with minimum of 10 years of experience in Bioanalytics or related discipline
• Experience in developing LC_MS/MS based quantitative assays required
• Excellent lab-based skills and the ability to work independently to analyze, interpret, and present data required
• Biotech and/or pharmaceutical industry experience required
• Demonstrated leadership and hands on experience in bioanalytical assay development, study execution, data analysis and reporting in a regulated environment preferred
• Excellent knowledge of bioanalytical guidance and direct experience with IND, NDA, BLA, MAA submission preferred
• Ability to multi-task to support multiple projects across platform
• Ability to work in matrixed environment
• Organized, excellent communication skills, highly collaborative, team player mindset

POSITION: Full-Time, Exempt