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Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The companys non-viral platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses its proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bios manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.
We are a thriving, collaborative, creative community of 140 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.
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Generation Bio seeks an energetic and highly motivated Senior Director to guide novel drug substance production and process research as part of the R&D organization. The production and process research department is focused on the preparation of our proprietary drug substance that is a non-viral, _in vivo_ gene therapy comprised of linear, double-stranded, closed-ended DNA (ceDNA). The department supports the supply of drug substance for all research activities such as pre-clinical screening in vitro and in vivo models. And will support development activities from within the company and with our partners. In addition, this team is charged with identifying improvements in the drug substance process to enable the production goals but also in creating next generation processes to support development activities. Drug substance is manufactured using traditional biologics equipment and infrastructure.
The Senior Director, Production and Process Research will provide technical, operational, and strategic leadership to support the development of a high-quality platform for production and process research activities. The successful candidate should have experience in stirred-tank reactors, cell expansion, harvesting and downstream purification using column chromatography platforms. Experience with viral gene therapy systems like AAV is preferred. A strong foundational background in molecular biology is preferred.
* Directing all research work for the manufacturing processes for drug substance which includes overseeing our production process and supply of drug substance in support of all early phase development activities.
* Manage and mentor a team of scientists engaged in the research of processes for the manufacturing for pre-clinical and clinical studies.
* Work closely with all teams within the R&D and CMC functions including Molecular Biology, Preclinical Research, Analytical Research, Analytical Development, and Process Development.
* Being responsible for the identification of next generation processes that improve drug substance yield and purity and maintain our vision of scalability.
* Collaborates with CMC and all other appropriate departments to define innovation strategies for process improvements which could ultimately be translated into robust production of drug substance.
* Communicating approaches and results to R&D and CMC team and other functions.
* Ph.D. in Biochemistry, Molecular Biology or equivalent.
* Minimum of 8 years relevant experience.
* Demonstrated experience in the technical development of a process to meet regulatory standards and expectations is preferred.
* Experience working with research collaborators including molecular and cell biologists and preclinical pharmacologists.
* Proven ability to identify process fault points and strategically implement new technologies for development of next generation processes.
* Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged.
* Ability to diversify technical skillsets in a fast-paced organization.
* Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes.
* Experience leading end-to-end cell line development programs is a plus.
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, religion, gender, national origin, 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
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