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Generation Bio Senior/Principal Scientist Upstream Process Development in Cambridge, Massachusetts

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 company’s 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 www.generationbio.com or follow @generationbio (https://twitter.com/generationbio) .

SUMMARY

Generation Bio seeks an energetic and highly motivated Sr/Princ Scientist to guide drug substance upstream process development as part of the Chemistry, Manufacturing and Control (CMC) department. The upstream process development team is focused on creating, optimizing and understanding the control strategy for a drug substance that is a non-viral, in vivo gene therapy comprised of linear, double-stranded, closed-ended DNA (ceDNA). Drug substance is manufactured using traditional biologics equipment and infrastructure.

The Sr/Princ Scientist will be responsible for building a team and developing a robust and scalable upstream process. This role will partner with Product & Process Research, Downstream Process Development, MS&T, Analytical Development, and Quality organizations to facilitate CMC advancement and success.

The ideal candidate must be comfortable with early phase IND programs, working in a fast-paced environment and familiar with using a risk-based approach to process characterization. The candidate should also have a thorough understanding of technical report writing and requirements of the CMC modules for an IND.

RESPONSIBILITIES:

Primary Responsibilities include:

  • Oversee the design and execution of small to large scale experiments using stir tank reactors (AMBR to 50L) to fully characterize process parameters that impact CQAs of the drug substance

  • Determine optimal parameters (DO, pH, temp, agitation ect) criteria for scale-up of baculovirus and baculovirus infected insect cell in STR systems

  • Manage project timelines and direct team to ensure deliverables including providing technical leadership to junior scientists in the execution of experiments

  • Stay current in new technology and regulations with respect to both process development and manufacturing

  • Evaluate, optimize, characterize and transfer novel/disruptive practices from Product & Process Research to MS&T/CMOs

  • Responsible for all PD Upstream technical documents including protocols, reports, policies, SOPs & risk assessments, etc. Coordinate information and documents for IP and regulatory filings

  • Conduct technical discussions & meetings with internal stakeholders including Product & Process Research, Downstream Development, MS&T and quality to facilitate implementation of new technologies. Present results at internal and external meetings

  • Assist senior management with departmental strategical planning and team growth including determining departmental equipment needs and justifying CapEx

  • Contribute to building a positive, team-oriented biotech culture

QUALIFICATIONS:

  • Ph.D. or equivalent in Biomedical Engineering, Biotechnology, or Biochemistry

  • Minimum of 5 years relevant experience.

  • Expertise with stirred tank and wave bioreactors; process development and scale-up (benchtop to at least 200L scale) for mAb, vaccine, or gene and cell therapies

  • Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged

  • Ability to diversify technical skills 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

  • Strong design of experiments (DOE) and data analysis skills

  • Strong written and verbal communication skills

Desired Qualifications

  • Knowledge and experience with the baculovirus vector system used as the expression system in cultured insect cells.

  • Knowledge and experience with AMBR scale bioreactors

  • Knowledge and experience with cell-based assays, qPCR, and ELISA

  • Knowledge and skills with TFF/ ATF, chromatography, and sterile filtration at lab-, pilot-, and manufacturing-scale

  • Publications in peer-reviewed journals

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.

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