Sr Engineer - Manufacturing, Science and Technology (MST)

Generation Bio

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/07/2021
  • Website: generationbio.com
  • Company Address: 215 First Street, Cambridge, Cambridge, MA, MA 02142

About Generation Bio

Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including ability to titrate to effect and re-dose. Our unique GeneWave technology allows us to overcome the limitations of other approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time.

Job Description

Description

 

Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of 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 diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.

Delve further. Please visit www.generationbio.com or follow @generationbio.

SUMMARY

Generation Bio seeks an energetic and highly motivated Sr. Engineer to join the Manufacturing, Science and Technology (MS&T) team and focus on ensuring a robust, scalable and efficient manufacturing process to produce LNP-based DNA gene therapy drug products for pre-clinical and clinical phase. Specifically, the person in this role will partner with Product & Process Research, Upstream Process Development, Downstream Process Development, Analytical Development, and Quality organizations to facilitate CMC advancement and success.

The Sr Engineer will be responsible for the initial and subsequent CMC programs in process scale-up, documenting the process control strategy, tech transfer and close communication with related CMOs. The ideal candidate should have experience in GMP, large scale bioreactors, column chromatography and TFF. 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 root cause investigations, technical report writing, change control and requirements of the CMC modules for an IND.

RESPONSIBILITIES:

Primary Responsibilities Include:

  • Partner with Contract Development and Manufacturing Organizations (CDMOs) to oversee drug substance at-scale & scale-up development and manufacturing activities.
  • Partner with internal peer groups within Product and Process Research (PPR), Upstream Process Development (UPS), Downstream Process Development (DSP), Analytical Development (AD) and Quality to build CMC strategies and tactics.
  • Work closely with the USP/DSP groups to establish key scale-related and manufacturing development strategies, including critical quality attributes (CQAs) for the production of the drug substance, which include key process parameters or ranges, in-process control strategy and release testing.
  • Work closely with the AD group to establish sampling and testing programs to achieve CQAs
  • Manages cross-functional technology transfer projects with a goal of developing the regulatory strategy for manufacturing operations.
  • Prepare, review, and approve process flow diagrams, development reports, and batch records.
  • Responsibility for relevant CMC source documents necessary for regulatory filings or health authority interactions.
  • Generate documents (scale-related development plans and reports, technical memos and protocols, etc.) related to CMC production and testing processes.
  • Provide support for all technology transfer projects for external vendors working on drug substance manufacturing. Identify, own and resolve technical process issues.
  • Executes process characterization projects and completes all required documentation, ex. research reports, characterization summaries, etc.
  • Identify opportunities to improve systems and practices, and drive harmonization across manufacturing platform.
  • Communicate approaches and results to senior management in the CMC, Quality, Pre-Clinical and Research and Development groups.

QUALIFICATIONS:

  • Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent
  • Minimum of 2 - 5 years relevant experience
  • Experience in development and scale-up of a gene therapy or related processes
  • Experience in tech transfer of a gene therapy technology
  • Experience in regulated environments (e.g. GMP manufacturing) required
  • Experience managing external vendors/contract organizations in a GMP setting
  • Ability to forecast manufacturing needs and obtain capacity at CMOs for each program
  • Ability to drive decisions with internal stakeholders in PD, Quality, and AD
  • 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 independence in execution and thought processes

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.

Related Jobs

Associate Scientist, Drug Product Analytical Development, contract

Generation Bio - Cambridge, MA, US

Scientist, Drug Product Analytical Development

Generation Bio - Cambridge, MA, US

Senior Director, Production and Process Research

Generation Bio - Cambridge, MA, US

Sr Engineer - Manufacturing, Science and Technology (MST)

Generation Bio - Cambridge, MA, US

Senior/Principal Scientist Upstream Process Development

Generation Bio - Cambridge, MA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.