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Sr Manager/Associate Director, Downstream Process Development

Boston, MA
Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss.
 
Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.
 
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.  Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
Job Summary:
 
The Process and Analytical Development group at Akouos is seeking an innovative candidate lead and to drive the downstream process development team for the establishment of methods to be used in the successful GMP manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Engineer with a strong background in AAV purification technologies and an excellent track record in gene therapy downstream process development. The successful candidate will actively participate in downstream process development, scale-up, process optimization, and tech transfer for GMP manufacturing. The successful candidate has experience building and leading teams of scientists or engineers. The successful candidate will thrive in a collaborative, scientifically stimulating, innovative and fast-pace environment.

Job Requirements:
  • Devise, oversee, and participate in the execution of downstream development strategy to support cGMP manufacturing
  • Drive design of experimental studies needed to support operating ranges and process improvements to enhance process reliability, improve process yields and develop strategies for scale-up, as needed, with an eye toward innovation
  • Effectively communicate objectives, strategies, and progress with key company stakeholders
  • Partner with the Upstream Process Development, Analytical, Research and Development and Regulatory teams to build effective CMC strategies for clinical candidates
  • Build an effective and collaborative technical team while mentoring and managing other scientists/engineers focused on downstream development
  • Drafting, review and completion of all appropriate documentation such as protocols, reports, batch records, regulatory sections to support INDs and other required documentation
  • Show an aptitude and ability to work with external contracted manufacturing and/or suppliers of critical materials for process development which are also suitable for GMP use
  • Manage materials and equipment vendor relationships and contribute to vendor, materials and equipment selection
  • Other duties as assigned
Job Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Degree in Chemical Engineering, Bioengineering or related discipline.
  • Ph.D. with a minimum of 8 years of industry experience in a biologics development setting or MS with 10+ years of relevant experience in biologics process development. BS with significant relevant technical experience will also be considered. 
  • Hands-on experience in developing scalable downstream processes is required
  • Demonstrated experience in effectively building and leading a technical team is required
  • A strong track record of working in a GMP or GMP-related processing environment
  • Separation/purification experience with viral particles is preferred
  • Demonstrated experience developing successful harvest, filtration, chromatography and other drug substance unit operation, purification, and processing techniques to support a cGMP compliant process
  • Capable of identifying internal and external resources required to execute on the strategy
  • Demonstrated experience in developing GMP production records and working with GMP Manufacturing and Quality staff to generate appropriate records suitable for use in the GMP manufacture of therapeutic products
  • 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
  • Goal oriented self-starter who will effectively and efficiently manage time, staffing and financial resources to effectively accomplish individual and corporate goal achievement on time and within budget
  • Significant viral vector downstream process development experience preferred
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