Scientist / Sr. Scientist- DMPK/BioD
Expiry Date :
Fri, 20 Aug 2021 23:59:59 GMT
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Generation Bio is an innovative genetic medicines company focused on creating a new class of non-viral gene therapy to provide durable, redosable treatments for people living with rare and prevalent diseases. The companys non-viral platform incorporates a proprietary, high-capacity DNA construct called closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle delivery system, or ctLNP; and an established, scalable capsid-free manufacturing process. The platform is designed to enable multi-year durability from a single dose of ceDNA and to allow titration and redosing if needed, and our scalable manufacturing process supports our mission to extend the reach of gene therapy to more people, living with more diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.
We are a thriving, collaborative, creative community of 120 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.
Delve further. Please visit [ follow @generationbio [
Generation Bio is seeking a highly motivated, enthusiastic, and skilled scientist to join our rapidly growing DMPK & Clinical Pharmacology team. The primary responsibilities for this position will include design/conduct and oversight of the in vitro and in vivo studies to characterize the pharmacokinetic behavior and biodistribution aspects of our proprietary non-viral vector-based gene therapy platform. These studies will support a broad range of activities including exploratory, preclinical and development stages of the pipeline across multiple therapeutic programs. In this role, the successful individual is expected to apply fundamental DMPK knowledge, employ cutting edge techniques to answer critical DMPK/BioD questions as they relate to pharmacology, toxicology in preclinical and clinical endpoints. The position also provides an opportunity for the individual to play a key role as a functional representative on program/platform teams and contribute to DMPK strategies in line with program objectives as well as regulatory expectations. Significant cross functional interactions are expected with key partnership between Pharmacology, Toxicology, formulations, and other departments.
* Design, conduct, and oversee in vitro and in vivo studies to understand pharmacokinetic and biodistribution behavior of our proprietary non-viral vector based gene therapies
* Responsible for the analysis, interpretation, integration, and reporting of DMPK data
* Develop tools for establishing pharmacokinetic-pharmacodynamic (PK/PD) response relationships to enable preclinical to clinical translation
* Participate in the management of CROs, including CRO selection and performance, to support DMPK studies
* Develop robust DMPK strategies to achieve project objectives and meet regulatory expectations
* Functional representative on platform team and/or project teams
* Participation in relevant external scientific communities or consortia efforts is highly encouraged
* PhD degree or a Masters with a minimum of 6 years and bachelors degree with a minimum of 8 years of experience in the fields of DMPK or formulations
* Knowledge in pharmacokinetics, ADME principles and biodistribution
* Experience in the gene therapy field (e.g. AAV) or targeted delivery (including lipid nanoparticle based delivery systems) is highly desirable
* Biotech and/or pharmaceutical industry experience is preferred
* Demonstrated leadership and hands-on experience in study execution, data analysis and reporting
* Independent thinking, effectively working in highly matrixed team setting and ability to multi-task in a fast pace environment
* Experience with cell culture and primary hepatocytes is a plus
* Personal attributes: Organized, fast learner, excellent communication skills, out of the box thinker, highly collaborative, team player
POSITION: Full-Time, Exempt
EEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.