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Scientist, CMC

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Company :
Generation Bio

Location :
Cambridge, Massachusetts

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Scientist, CMC

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 [ or follow @generationbio [

SUMMARY

Generation Bio seeks an enthusiastic and highly motivated Scientist to drive development of our novel gene therapy product. This position joins a team of scientists dedicated to developing upstream and downstream processes to support the manufacture and optimization of early-stage clinical material. The successful candidate will champion the continual improvement of our novel process to support several clinical drug substance candidates. Candidates with 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 an extensive pipeline.

The person in this position will specifically be responsible for development of a robust and reproducible high throughput, small scale, downstream process to rapidly determine ceDNA (close ended DNA) yields from process optimization and scale-up studies. This person should have experience with high throughput downstream methods and an understanding of orthogonal ways for analysis of DNA. This person will play a critical role in establishing a robust, scalable, and optimized manufacturing process of Generation Bios DNA based gene therapy product. The person in this role will collaborate with staff in R&D, process development, MSAT, and analytical teams to facilitate drug substance advancement and success.

RESPONSIBILITIES:

Primary responsibilities for this role include:

* Develop a rapid, high throughput and scalable purification process steps including depth filtration, TFF, and chromatography (IEX, affinity, mixed mode).
* Execute downstream runs, coordinate sample analysis, data organization, and write study reports.
* Support process development activities to achieve key development milestones.
* Author study plans, protocols, and reports.
* Supervise, train and mentor junior staff.
* Design, prioritize and execute experiments for operating ranges and process improvements.
* Prepare, analyze, and present data internally to cross functional teams.
* MS or equivalent experience in Biomedical Engineering, Biotechnology, or Biochemistry
* Proven technical proficiency in downstream process development and high throughput systems.
* Result-driven with excellent attention to details
* Ability to manage multiple projects and responsibilities simultaneously.
* Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes.
* 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.

QUALIFICATIONS

* MS or equivalent experience in Biomedical Engineering, Biotechnology, or Biochemistry
* Proven technical proficiency in downstream process development and high throughput systems.
* Result-driven with excellent attention to details
* Ability to manage multiple projects and responsibilities simultaneously.
* Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes.
* 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, 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 applicable law.