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Associate Director / Director, Downstream Process Development

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 enthusiastic and highly motivated Associate Director/Director to drive the vision and strategy as the head of the downstream development group. The successful candidate will report to the Director of Process Development and joins a team of scientists dedicated to developing scalable downstream processes that will support cGMP manufacturing for early stage filing with regulatory authorities. This downstream group leader will devise group strategy that includes continual improvement of our GMP compliant process, bringing on the next generation of our downstream process. This role will have high visibility in a company that is expanding to support a dynamic pipeline.

RESPONSIBILITIES:

Primary responsibilities of this position include:

  • Develop and oversee execution of downstream strategy to support cGMP manufacturing for multiple clinical stage programs
  • Drive design of experimental studies needed to support operating ranges and process improvements
  • Support the generation of material for multiple programs at the IND enabling study stage
  • Management of direct reports
  • Drafting, review and completion of all appropriate documentation such as protocols, reports, etc.
  • Interface with internal cross-functional teams and tech transfer processes to CMOs
  • Scale-down model development
  • Lead key projects targeting at bringing about the next generation of the downstream process

QUALIFICATIONS:

Required Qualifications

  • PhD in Biochemistry, Chemical Engineering, Bioengineering or related discipline with 8+ years of relevant experience or MS with 10+ years of relevant experience
  • Proven technical proficiency in the area of downstream process development: purification of nucleic acids or viral gene therapies is preferred
  • Demonstrated experience developing cGMP strategies and identifying internal and external resources to execute on the strategy
  • Proven technical expertise in development of scalable and commercially viable processes
  • Ability to lead and manage tech-transfer activities to CMOs
  • Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
  • An ability to adapt to a dynamic environment

Preferred Qualifications

  • Experience with early stage process development of novel target molecules
  • Hands on technical experience in development of unit operations including cell harvest, lysis, depth filtration and chromatography steps (IEX, affinity, mixed mode, etc)
  • Experience managing and developing scientists
  • Track record of managing multiple projects

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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