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Director, Manufacturing, Science and Technology (MST)

Cambridge, Massachusetts, United States

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 Director to establish the Manufacturing, Science and Technology (MST) function which will focus on ensuring a robust, scalable and efficient manufacturing process to produce DNA gene therapy products for pre-clinical and clinical phase. Specifically, the MST Director will partner with Process Development, Research Production, Analytical Development and Quality organizations to facilitate CMC advancement and success. Ultimately, the MST Director will establish this key service and support organization which will facilitate the operations of Generation bio’s CMC programs. The successful candidate should have experience in the gene therapy field and CMC development from early to IND stage and have a key understanding of technical needs for the regulatory standards and expectations at these milestones.

RESPONSIBILITIES:

  • Focus on process engineering and scale-related development components for our upstream and downstream processes
  • Partnering with peer groups within Process Development, Research Production, Analytical Development and Quality to build CMC strategies and tactics. Work closely with the Process Development group to establish key scale-related and manufacturing development strategies, including critical quality attributes (CQAs) for the production of drug substance and drug product, including key process parameters or ranges, in-process control strategy and release testing
  • Will manage the hiring and growth of a team of MST scientists to advance the development, scale and efficiency of CMC productionWork closely with the Analytical Development scientist to establish sampling and testing programs to achieve the CQAs
  • Leads and manages cross functional technology transfer projects and all process and analytical development programs with a goal of developing the regulatory strategy for manufacturing operations
  • Also, acts as lead and manages CMC peer teams to ensure success of scale up/process transfer. Includes authoring of upstream or downstream plan documentation and associated detail process descriptions
  • 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 of all technology transfer projects for both internal and external vendors working on drug substance and drug product manufacturing. Identify, own and resolve technical process issues in a timely manner
  • Accurately forecast and drive project plan of assigned MST objectives
  • Executes process characterization projects and completes all required documentation, ex. research reports, characterization summaries, etc.Identifying opportunities to improve systems and practices, and drive harmonization across manufacturing platform
  • Responsible for the compliance of these efforts with Generation Bio and regulatory standards.Communicating 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 10 years relevant experience
  • Experience in development of gene therapy or related DNA-based processes
  • Experience in regulated environments highly desired, with experience in a GMP setting.
  • Experience managing with external vendors/contract organizations also in a GMP setting.
  • Ability to drive decisions with internal stakeholders in Process Development, Quality, and Research.
  • 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 managing and building a team

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.

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