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Principal Associate Scientist, Downstream Process Development

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Company :
Generation Bio

Location :
Cambridge, Massachusetts

Expiry Date :
Wed, 18 Aug 2021 23:59:59 GMT

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Description :
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 [

SUMMARY

Generation Bio seeks an enthusiastic and highly motivated Scientist to drive development of downstream processes for production of our novel gene therapy product. This position joins a team of scientists dedicated to developing downstream processes to support the manufacture of early stage clinical material. The successful candidate will champion the continual improvement of our GMP compliant process to support several clinical drug substance candidates. Candidates with proven downstream process development experience and an ability to adapt to a dynamic environment will be highly valued. This role will have high visibility in a company that is expanding to support a dynamic pipeline.

RESPONSIBILITIES:

Primary responsibilities for this role include:

* Develop scalable and commercially viable processes for the purification of our novel genetic medicines.
* Support downstream activities both internally and externally to achieve key development milestones
* Author study plans, protocols, and reports.
* Design, prioritize and execute experiments including, operating range studies and process improvements.
* Manage and execute inhouse lab work and studies supporting the development and generation of material for preclinical and clinical testing.
* Support scale up of process steps including filtration (depth filtration, UFDF, sterile filtration), and chromatography (affinity, IEX etc).
* Support downstream tech transfer to CMO and build strong relationships with collaborating companies.
* Prepare, analyze, and present data internally to cross functional teams.

QUALIFICATIONS

* BS in Chemical Engineering, Biotechnology or related discipline with minimum 6+ years of relevant experience or Masters Degree with minimum 4+ years of relevant experience.
* Proven technical proficiency in downstream process development
* Ability to manage multiple projects and responsibilities simultaneously.
* Strong collaboration and team working skills
* Proven ability to work independently, effectively plan and analyze work activities and prioritize task completion to meet schedules and deadlines.
* Knowledge of cGMP, FDA and USP guidelines practices 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, 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.